Careers

Working Together Toward a Shared Vision

At Allena, we’re proud of our dynamic, thoughtful and engaging culture, and we are always looking for outstanding professionals to join our team.

We are innovators and collaborators. We fully appreciate our responsibility to the patients and to our stakeholder community, which is supporting our efforts to advance the development of novel oral enzyme therapeutics to treat complex metabolic complications.

To be considered for one of the positions below, please complete the form below and send us your resume. 

Director, Process Development

Description:

The Director of Process Development will establish the strategy, project plans, and timelines for internal/external process development efforts to characterize and optimize the late-stage Reloxaliase process as a lead-in to process validation, commercialization and process monitoring. Additionally, the Director of Process Development will grow the PD function within the company and lead the creation of subsequent manufacturing processes for clinical candidate compounds with an emphasis on translating academic/R&D processes into scalable, robust methods suitable for industry and subsequent technology transfer into a GMP manufacturing environment.

The individual chosen for this role will work in close partnership within a matrixed environment by regularly interfacing with diverse teams and functions including MSAT, Quality, Regulatory, Legal, Analytical Development, and Program Management.

Responsibilities:  

The Director of PD will be responsible for primarily downstream PD activities with some peripheral involvement in upstream development activities. Those duties include:

  • Assessing and refining the strategy for Allena’s PD group with an immediate focus on completing the actual process development and “locking” the process to be used for GMP runs and PPQ (process validation) of our lead candidate
  • Working closely with other necessary department heads to develop a tech transfer plan for processes coming from PD and moving into GMP manufacturing
  • Lead an internal team consisting of Analytical Development, MSAT and External Manufacturing to determine a robust Process Performance Qualification (PPQ) protocol strategy, to include generation of appropriate acceptance criteria
  • Responsible for the all stages of process development for all programs within the pipeline
  • Oversee the development and implementation of an (upstream and downstream) process monitoring/control strategy program using appropriate statistical guidelines
  • Provide expert and scientific input into the development and implementation of drug substance and drug product release specifications 
  • Leads authoring efforts for specific CMC sections of regulatory filings (including INDs, BLA’s, and formal responses to regulatory inquiries)
  • Drives innovation from ideation to realization for process improvements, including definition of technology roadmap, justification of projects, and developing implementation plans.
  • Support business cases and CAPEX justifications for capacity expansion, facility build-outs and acquisitions
  • Participates in planning to ensure alignment between resource availability and project pipeline 

Skills/Abilities:

  • A demonstrated self-starter who is excited by the challenge of commercializing a late-stage product and values the direct impact he/she will have on the lives of our patients
  • Willing and able to work at whatever operational level needed to meet the goals of the function 
  • Highly motivated and ability to take a proactive approach on the job
  • Has a solid understanding of business and financial fundamentals
  • Willing to challenge the status quo and provide creative solutions to identified challenges

Competencies:

Results orientated: Sets challenging yet achievable goals; pursues them persistently, overcome obstacles while focusing on meeting or exceeding these goals. Plans out work, organizes resources and monitors progress. Has a strong desire for Allena, own team, and self to succeed.

  • Constantly pushes self for best results 
  • Demonstrates a “can-do” spirit 
  • Figures out the process necessary to get things done
  • Monitor process, progress and results
  • Understand how to separate and combine tasks into efficient work flow
  • Works tirelessly to meets goals successfully

Communication: Promotes a smooth flow of information and communication throughout Allena. Communicates effectively and often with all audiences. Openly shares knowledge and expertise. Listens actively and encourages others to express their ideas and opinions.

  • Ask questions in order to confirm understanding 
  • Effective communicator in a formal setting: one-on-one, small and large groups, with peers and bosses
  • Has good judgment as to what information is significant and useable in each situation
  • Listens to feedback, comments from superiors and colleagues
  • Organizes ideas in a clear, logical flow that can easily be followed by the audience
  • Practices effective listening skills
  • Shares information with others regularly and often to promote free flow of information
  • Writes and speaks clearly and succinctly in a variety of communication settings

Collaboration: Develops and uses collaborative relationships to facilitate the accomplishment of work goals. Fosters collaboration among team members and among teams. Involves others in decisions and plans and credits them for their contributions and accomplishments. Fosters enthusiasm and maintains mutual trust, candor and respect.

  • Uses team approach to solve problems when appropriate
  • Understands the dynamic of the group in terms of positions, roles, expectations and needs
  • Works with other units/teams/functions to accomplish goals
  • Learns new skills and knowledge and shares that with the team
  • Encourages collaboration and is cooperative
  • Shares best practices and knowledge with others

Education and Experience:

  • PhD in a life science and 5-7 years of experience in large-molecule, biologics-related PD, an MS and 10 years of experience, or a BS/BA and 12 years of experience 
  • Must have expertise in and be able to demonstrate a deep understanding of end-to-end bioprocessing strategies to include the current state of the art analytical tools used to evaluate them
  • Has a deep technical understanding of large-molecule and large-scale manufacturing platforms
  • Demonstrated experience in late-stage product development including execution of product risk assessments, implementation of Quality by Design and integration of RA and QbD into process validation protocols and BLA submissions
  • An excellent leader with experience managing teams of high-performing PD scientists/engineers

Location: Sudbury, MA

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Director, External Manufacturing (Drug Substance)

Description

The Director of External Manufacturing (Drug Substance), will form a key part of a vital External Manufacturing & Operations function. This function is growing to meet the business needs of Allena’s maturing CMO network. This role manages the operational relationship with multiple Contract Manufacturing Organizations (CMOs) in preparation for commercialization of the company’s lead product. The Director is responsible for operations performance of all external manufacturing within Allena’s Commercial Contract Manufacturing Organization (CMO) network under their remit. This role partners with both internal and CMO functional peers to ensure adherence to Allena’s manufacturing standards, budgets, outputs and schedules.  The Director will lead and coordinate multiple cross-functional operations teams to ensure CMO manufacturing is proactively supported. The role is responsible for establishing strategy, implementing actions, reporting status, identifying / mitigating risks and driving a culture of continuous improvement. The role drives for excellence in PAI and routine cGMP Inspection performance and will support the development of BLA, NDA and other regulatory filings.

Who are we looking for?

  • An External Manufacturing/Drug Substance Leader who loves working on multiple projects in a fast-paced, cross-functional team environment
  • Minimum of bachelor’s degree in Life Sciences discipline appropriate to cell therapy programs (immunology, cell biology, genetic engineering, etc.)
  • 10+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development. Fluency in cGMP requirements.

What are we looking for?

  • Leading the way:  A creative and learning-agile leader, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company
  • Manager who is a proven mentor and coach
  • Career support and leadership opportunities within the CMC group

Responsibilities:  

  • Lead and direct Allena and CMO cross-functional tiered meeting structures to ensure business objectives and manufacturing, supply and quality deliverables are met.
  • Ensure issues are effectively resolved and that supply risks are being proactively managed
  • Build and maintain strong relationships with CMO and internal peers to develop and deliver shared objectives
  • Ensure timely escalation of issues and risks as relevant to appropriate stakeholders
  • Provide operational expertise to support all aspects of the manufacturing of commercial and late stage clinical pharmaceutical products at CMOs
  • Develop, maintain and communicate suitable KPIs to measure CMO / Allena performance to ensure business and patient supply needs are achieved
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners
  • Support the Allena executive teams at Joint Steering Committee (lJSC) meetings where appropriate. Drive internal cross functional alignment on key issues as outcome of these CMO engagement meetings
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices
  • Support identification and implementation of continuous improvement initiatives within the External Manufacturing & Operations team
  • Work closely with internal peers to adopt, promote and improve the External Manufacturing & Operations model
  • As needed support CMO due diligence during new CMO selection to vet capabilities, risks and investments required
  • Engage, as needed, in contract negotiation and review. After execution of a contract, act as contract monitor, ensuring both Allena and the CMO comply with commitments.
  • Provide regulatory filing support (IND, BLA, etc.)
  • Inventory management (in partnership with Drug Product/Supply Chain)
  • Drive a continuous improvement mindset (e.g. process improvements: throughput, cycle time, robustness)
  • Maintain financial responsibility for CMO spend, managing the budget allocation, negotiating work statements, ensuring purchase requisitions are raised and PO’s are reconciled 
  • Oversee change management (pre- and post-approval), ensuring owners are identified and change controls are raised and assessed in a timely manner.

Skills/Abilities:

  • Extensive knowledge of a variety of drug substance manufacturing unit operations used in USP and DSP of large molecule products from microbial fermentation. Prefer candidates with microfiltration and ultrafiltration experience
  • Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections
  • Demonstrated experience with technology transfers and scale-up of manufacturing processes
  • Experience of working with CMOs demonstrating strong communication and influencing skills
  • Ability to demonstrate strategic thinking and risk management
  • Systems and process development, optimization and implementation

Competencies:

Passion for Innovation: Generates and champions new ideas, approaches, and initiatives, and creates an environment that nurtures and supports innovation. Leverages knowledge and best practices, fresh perspectives, breakthrough ideas, and new paradigms to create value. Encourages new ways of looking at problems, processes, or solutions.

Planning: Creates a comprehensive and realistic business plans by defining deliverables, milestones, accountabilities and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests and due dates. Allocates appropriate amounts of time for completing own work. Prioritize critical and less critical activities. Proactively plans to avoid problems.

Collaboration: ls and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Adaptability: Responds resourcefully, flexibly and positively when faced with new challenges, transitions and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. 

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness.  Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance.  Addresses problems directly and drives changes necessary to achieve business objectives.

Education and Experience:

  • Bachelor’s degree in Life Sciences discipline appropriate to cell therapy programs (immunology, cell biology, genetic engineering, etc.)
  • 10+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development. Fluent in cGMP requirements
  • Demonstrated ability to lead matrix teams
  • Demonstrated experience in management of external partners

Location: Sudbury, MA

Travel: 20%+ (routine travel to CMO sites)

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Executive Director/Senior Director Quality Assurance

Description

This position is a key senior leadership role at Allena, reporting directly to the SVP of Technical Operations. The Executive / Senior Director of Quality is responsible for establishing, enhancing and managing the Allena quality and compliance activities within Allena and across a network of outside contractors (CRO, CDO, CMO) responsible for development, ongoing manufacture and eventual commercialization of Allena’s products. This role will operate at an executive level to define the strategy for product quality management at Allena across both early-stage and late-stage clinical products. The primary responsibilities of the position are to prepare the company for preapproval inspection and commercialization while simultaneously developing and refining quality systems and building/leading a small organization to prepare for inspection and oversee product quality at all 3rd party contractors, while ensuring high levels of quality and service to internal customers, positive experience of staff, and meeting departmental initiatives. The ideal candidate for this role is an experienced, natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, and who can communicate effectively with executive leaders and key leaders from external partners and customers.

Who are we looking for?

  • Innovative Quality leader to lead our strong, reliable and high performing QA team
  • Must be versed in all relevant GMP and GLP guidance with preference to candidates with GCP experience as well.
  • Strong preference for candidates with CFR 210/211, EMEA Annex 1 experience, in addition.
  • Leader with 15+ years minimum experience in the Quality/Supplier Quality field in life sciences, pharma or biotech.

What are we looking for?

  • Leading the way:  A creative and learning-agile QA leader, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company
  • Manager who is a proven mentor and coach
  • Career support and leadership opportunities within the CMC group
  • Membership within a growing, CARING and collegial organization

Responsibilities:  

  • Enhancing and maturing the vision for corporate quality at Allena as an emerging biotech.
  • Act as key strategic driver in integrating the role of quality into the business with the executive committee.
  • Lead a cross functional group at establishing an industry standard quality system that interfaces with all key business components.
  • Develop a mid-term roadmap for preapproval inspection and oversee the development of a team that will manage execution on the plan.
  • Help oversee the development of a nimble, risked-focused quality system architecture that can flex across different clinical stage products, risk profiles, and sources/CMOs.
  • Drive QBD initiatives into product development to help enable best practices in building manufacturable products.
  • Represent Allena quality in all partner / customer interactions.
  • Define quality policy and cross-company RACI matrix.
  • Develop a best in class program for supplier management and auditing, as well as internal audit management.
  • Oversee the ongoing management of the Quality Document Control and the sourcing, design, and implementation of a comprehensive Quality Management system.
  • Enhance, drive and report on the CAPA/OOS/OOT and investigations programs.
  • Mature the quality governance system that tracks the business with internal and external KPI’s and holds departments/CXOs accountable on deliverables.
  • Ensuring management of changes associated with products and processes are carried out appropriately using science and risk-based assessment to determine the impact of change.
  • Monitoring, communicating and acting on any emerging compliance trends that may potentially impact on product quality.
  • Provide direction and mentorship to management staff.
  • Oversees departmental product issues and commits resources to understand root cause root and appropriate corrections.
  • Select, train/orients and schedules department staff. Develops standards of performance, evaluates KPIs, and initiates or makes recommendations for personnel actions.
  • Provide regular KPIs and other metrics to senior management.

Skills/Abilities:

  • Must be versed in all relevant GMP and GLP guidance with preference to candidates with GCP experience as well.
  • Strong preference for candidates with CFR 210/211, EMEA Annex 1 experience, in addition.
  • Experience with large-molecule, fermentation-derived products is a plus.
  • Excellent communication skills, both written and verbal.
  • Demonstrated skills in problem identification, analysis and resolution.
  • Demonstrated ability to assess needs, train and supervise staff.
  • May have had department-level leadership responsibilities with a commercial company.
  • Strong preference for candidates with global experience.

Competencies:

Planning: Creates a comprehensive and realistic business plans by defining deliverables, milestones, accountabilities and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests and due dates. Allocates appropriate amounts of time for completing own work. Prioritize critical and less critical activities. Proactively plans to avoid problems.

Collaboration: ls and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Adaptability: Responds resourcefully, flexibly and positively when faced with new challenges, transitions and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. 

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness.  Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance.  Addresses problems directly and drives changes necessary to achieve business objectives.

Education and Experience:

  • Bachelors degree in scientific discipline (Biology, Chemistry, Engineering), MS/PhD a plus
  • 15+ years minimum experience in the Quality/Supplier Quality field in life sciences, pharma or biotech
  • 15 years in leadership roles in increasing responsibility
  • 3+ years experience in senior/direct-line position at an organization that underwent PAI and/or regular audits by customers / regulatory agencies required

Location: Sudbury, MA

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

VP of Clinical Operations

Description

The Vice President of Clinical Operations will be responsible for the strategic oversight, execution (within budget and timelines), compliance and day-to-day management of the clinical operations team, as well as CRO management for investigational and marketed products. She/he will identify and drive strategic initiatives for clinical trial planning, execution, close out, and continuous process improvements. The Vice President will be accountable for the line management of Clinical Operations Team members, including development, coaching, and talent planning and performance management. 

Who are we looking for?

  • Innovative VP of Clinical Operations who will help Allena’s Clinical Operations team in execution of their goals.
  • Ideally a minimum of 15 years of directly related experience in drug development, including running multiple concurrent large global phase 3 trials and NDA/BLA regulatory filing experience.
  • Significant management experience including outsourcing to Contract Research Organizations (CROs) and other clinical trial vendors.

What are we looking for?

  • Leading the way:  A creative and learning-agile clinical leader, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Primary strategic leadership role for overall clinical operations activity and execution of global clinical trials in alignment with Program Team goals
  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company

Responsibilities:  

  • Manages vendors and consultants relevant to the supported function (such as statistics, medical writing), including consulting agreements, contracts and related budgets and invoicing.  Specifically, responsible for managing the Duke Clinical Research Institute (DCRI) collaboration, and non-clinical trial research projects (such as OM-1 database research project); may support expanded access program. 
  • Manages selected meetings, including scheduling, preparing meeting minutes, timelines, tracking action items, driving deliverables; works with colleagues across projects and functions to understand and take into consideration cross-project overlap and existing resources within CD/MA to streamline their activities and deliverables. 
  • Identifies critical resource gaps and suggests and implements solutions and mitigation; will provide direct hands-on assistance as needed. 
  • Prepares or assists in the preparation of presentations to internal and external stakeholders and supports/manages the preparation of abstract/posters/manuscripts and other documents with internal reviewers and external contributors (e.g., external medical writing, authors); contributes content as appropriate, consolidates comments and resolves issues. 
  • Coordinates/assists with preparation for Advisory Board meetings, Allena presence at national and/or regional scientific meetings; includes supporting logistical management of vendors, investigators, Allena personnel at academic/scientific meetings and attending meetings.
  • Gains and maintains knowledge of therapeutic area and current medical practice; helps with hands-on consolidation/organization of data to support medical functions and business development.

Skills/Abilities:

  • Manage reports up through Executive Director Level within the Clinical Operations line function: attract as needed, supervise, mentor and ensure high performance of Clinical Operations staff. Ensure appropriate and high performing staffing of the line function to meet clinical deliverables. Evaluate resource requirements, including people and develop efficient and comprehensive resourcing plans across all clinical studies.

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives. 

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

People Development: Creates comprehensive and robust talent plans, talent pools, and bench strength within the organization. Ensures that talent receives feedback, mentoring, training and development opportunities. Shapes roles and assignments in ways that leverage and develop individual’s capabilities. ​

Education and Experience:

  • BS/BA degree in related discipline and 20 years of related experience; or,
  • MS/MA/MBA degree in related discipline and 15 years of related experience; or,
  • PhD in related discipline and 12 years of related experience.
  • Ideally a minimum of 15 years of directly related experience in drug development, including running multiple concurrent large global phase 3 trials and NDA/BLA regulatory filing experience.
  • Significant management experience including outsourcing to Contract Research Organizations (CROs) and other clinical trial vendors.
  • Extensive experience managing Clinical Operations staff and optimizing resources across clinical studies.

Location: Newton, MA

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Senior Director/Executive Director, Medical Affairs

Description

Allena Pharmaceuticals is recruiting for a professional with experience in conducting high level scientific and strategic interactions with external thought leaders and internal stakeholders, to join our team based in Newton MA. Reporting to the Chief Medical Officer, the Senior /Executive Director Medical Affairs will be responsible for developing and managing the medical affairs organization, and oversee all related activities including supporting clinical trial recruitment, developing opinion leader relationships, raising disease awareness, and managing data dissemination. 

Who are we looking for?

  • Innovative Medical Affairs leader who will build Allena’s Medical Affairs department and support Clinical Development, Clinical Operations and Commercial teams in execution of their goals.
  • Minimum 10 years of pharmaceutical/biotech industry experience in Medical Affairs or related areas (Research & Development), and experience managing and leading Medical Affairs team.
  • MD Nephrologist or Urologist, or PharmD/PhD with extensive experience in nephrology or urology.

What are we looking for?

  • Leading the way: A creative and learning-agile clinical leader, willing to challenge the status quo
  • Ownership: A partner to jointly own our company’s goals, execution and success
  • Working together: A colleague to thrive on collaboration with our teammates
  • Loving what you do: A team member with positive energy that is passionate about our mission

What are we offering?

  • Primary strategic leadership role to drive Allena Medical Affairs priorities, and develop and execute the Medical Affairs plan
  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company

Responsibilities:

  • Scope out Allena Medical Affairs priorities and develop Medical Affairs plans.
  • Identify,develop and maintain compliant relationships with KOLs and other critical stakeholders; cultivate partnerships with Advocacy Groups and other organizations. 
  • Support Pl engagement and recruitment of Phase Ill studies , working closely with Clinical Development and Clinical Operations.
  • Develop and oversee the Medical Science Liaisons team that will support PI engagement and recruitment, develop and maintain KOL relationships and raise disease awareness.
  • Develop and maintain deep scientific knowledge of Allena products and target disease states, as well as a solid understanding of the overall healthcare landscape, including physician communities and their practice patterns in order to support cross-functional objectives
  • Plan Allena participation in scientific meetings and congresses, and plan and lead medical education activities, such as advisory boards, congress symposia, steering committees and stakeholder meetings, and ensure appropriate cross-functional communication of insights and feedback
  • Oversee and lead the development and execution of publication and congress plans to raise disease awareness and optimize data dissemination for reloxaliase and other Allena pipeline assets.
  • Contribute to the planning and oversight of non-registrational studies (e.g., phase IV, registry, expanded access), other data generation activities such as investigator­ initiated research studies, and the planning/executing the HEOR strategy.
  • Handle day-to-day medical, and scientific questions from internal and external sources, and lead preparation of responses to medical information queries

Education and Experience: 

  • MD, PharmD, or PhD; experience in nephrology or urology preferred. MSc with Medical Affairs leadership experience in nephrology or urology considered.
  • Minimum 10 years of pharmaceutical/biotech industry experience in Medical Affairs or related areas (e.g., Research & Development), and experience managing and leading Medical Affairs team.
  • Motivated, self-starter who operates well in a smaller organization with demonstrated track record of building Medical Affairs capabilities.

Skills/Abilities: 

  • Maintains cross-functional collaboration with internal functions & field teams to provide scientific expertise and advisement
  • Excellent communication and presentation skills both written and verbal, and strong experience with medical communications and publication planning
  • Strong project leader and effective team member with strong cross-functional orientation and collaboration; excellent interpersonal skills
  • Excellent problem solving, organizational, and negotiating skills
  • Travel up to 50%, including overnight and weekend commitments

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Remote in the COVID era; post COVID, Corporate Offices in Newton, MA

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All resumes submitted by search firms/employment agencies to any employee at Allena via email, the internet or in any form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Research Assistant (Research Associate), Analytical Development

Description

The Analytical Development Research Assistant/Associate will be responsible for performing bioanalytical assays to support activities such as stability, characterization, and process development. Successful candidates should have laboratory training, experience working with proteins and large molecules, experience maintaining laboratory notebooks and providing data summaries.

Who are we looking for?

  • Energetic individual who will work with the Analytical Development team contributing to a variety of novel projects and is interested in a laboratory centric career 
  • Must have 1-3 year of laboratory experience supporting drug development in a laboratory environment.

What are we looking for?

  • A creative and focused (attention to details is a must) analytical scientist, able to consistently deliver results to drive research projects forward
  • A colleague to join our lab as both an individual and team contributor
  • A team member with positive energy who is passionate about asking questions and finding answers.

What are we offering?

  • Membership within a growing, CARING and collegial organization
  • An opportunity to grow with the Analytical Development role and CMC
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites

Responsibilities:

  • Perform and record analyses.
  • Review peer's work as needed.
  • Develop and/or review revisions to procedures.
  • Provide data summaries, presentations, and detailed reports.
  • Support method development activities.
  • Assist in maintaining a clean, safe workplace.
  • Familiar with proper preparation and use of laboratory solutions (buffers, mobile phases, solvents, etc.).
  • Maintenance of laboratory notebook and records in accordance with laboratory requirements, including timely recording of information and review.

Education and Experience: 

  • Bachelor’s Master’s Degree in Analytical Chemistry, Biochemistry, Molecular Biology or related field.
  • 0-4 years of relevant experience (or equivalent combination of education and experience).

Skills/Abilities: 

  • Knowledge of basic chemical reactions and equilibria.
  • Experience or knowledge of the set up and use of spreadsheets for analysis of results.
  • Knowledge of basic statistics (SD, RSD, etc.) 
  • Hands on experience performing several of the following techniques: Bioassays, ELISA, HPLC, SDS-PAGE, capillary electrophoresis, immunoblots, dynamic light scattering, powder flow evaluation and spray drying.
  • Ability to function in a chemical laboratory environment; should have no known sensitivities to chemicals present in the laboratory and no health conditions that preclude working in a chemical laboratory environment. 

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Remote, Newton & Sudbury, MA

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All resumes submitted by search firms/employment agencies to any employee at Allena via email, the internet or in any form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Process Development Associate

Description

Allena is seeking a highly skilled and motivated Process Development Associate to reside in Allena’s Process Development organization in Sudbury, MA. This role will support both the early-phase process development of Allena’s pipeline products and process characterization of the company’s late-stage lead product. The applicant should have strong communication and collaboration skills, along with multiple examples of strong technical contribution in large molecule downstream process development.

Who are we looking for?

  • Energetic individual who will work with the Process Development team contributing to a variety of novel projects and is interested in a laboratory centric career 
  • Must have 1-3 year of laboratory experience supporting process development in a laboratory environment.

What are we looking for?

  • A creative and focused (attention to details is a must) chemist or chemical engineer, able to consistently deliver results to drive research projects forward
  • A colleague to join our lab as both an individual and team contributor
  • A team member with positive energy who is passionate about asking questions and finding answers.

What are we offering?

  • Membership within a growing, CARING and collegial organization
  • An opportunity to grow with the Process Development role and CMC
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites

Responsibilities:

  • Support the design and execution of lab scale and pilot scale studies (bench scale to 100 L scale) to evaluate new technologies, improve existing technologies and assist in the implementation of new/improved processes for clinical and commercial product purification
  • Assemble, operate, CIP, and maintain bench and pilot scale unit ops equipment (tangential flow filtration units, disc stack centrifugation, crystallizer, spray dryer, homogenizer, pumps, chillers, instrumentation)
  • Support the development of 2nd generation downstream process for the late phase programs 
  • Execute studies in support of late-phase process characterization activities including: risk assessments, scale down model qualification, pre-characterization and characterization experiments, impurity clearance studies, and development of the PPQ and commercial process control strategy
  • Support process transfer and scale up 
  • Apply engineering concepts to the screening, optimization and scale-up of solids isolation/removal and filtration processes including flocculation, microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration
  • Collaborate within cross-functional teams (Analytical Development, MSAT, Quality, and External Manufacturing) to deliver required CMC activities
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner 
  • Prepare scientific presentations and author technical reports as needed
  • Maintenance of laboratory notebook and records in accordance with laboratory requirements, including timely recording of information and review.

Education and Experience: 

  • BS degree in biochemistry, chemistry, chemical engineering, bioengineering, or related area with 2-4 years of industry experience/ or MS degree in biochemistry, chemistry, chemical engineering, bioengineering, or related area with 0-2 years industry experience in recombinant protein or biomolecule purification processes is required
  • A good understanding of protein chemistry, bioprocessing technology, and protein analytics is required

Skills/Abilities: 

  • Hands-on experience and understanding of downstream processing of biologics in industry or in an undergraduate or graduate laboratory setting is required: experience with tangential and normal flow filtration and centrifugation is preferred and experience with protein crystallization and spray drying is a plus
  • Experience with analytical assays such as SDS-PAGE and protein concentration analytical methods is preferred
  • Strong data organization skills, interpretation and troubleshooting are critical to be successful
  • Demonstrate independent problem-solving skills of technical issues; develop solutions to a variety of moderate to complex problems
  • Exercise judgement within defined procedures and practices to determine appropriate action
  • Experience at working both independently and in a team-oriented, collaborative environment is essential

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Remote, Newton & Sudbury, MA

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All resumes submitted by search firms/employment agencies to any employee at Allena via email, the internet or in any form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

CMC Project Manager or Senior CMC Project Manager

Description

We are seeking an experienced CMC Project Manager or Senior CMC Project Manager to drive the delivery of pipeline assets and technical projects. In this position, you will help drive the overall success of our clinical programs within Technical Operations. The position will work collaboratively with functional area leads and their program teams to plan, track and report the diverse activities managed by Technical Operations. This includes, but is not limited to, process development, analytical development, tech transfer, regulatory documentation, clinical manufacturing, commercial planning, project strategy and vendor management. This is an exciting and visible role for a highly qualified and motivated individual. 

What are we offering?

  • Membership within a growing, CARING and collegial organization
  • An opportunity to grow, develop skills and have fun
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites

Responsibilities:

  • Partner closely with CMC functional areas to develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for the project
  • Track and monitor key milestones and decision points to drive delivery of project objectives
  • Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects 
  • Ensure team members are aware of integrated project timelines, and provide timely updates that may have cross-functional impact 
  • Facilitate team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives 
  • Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies using preferred technologies
  • Effectively manage internal and external resources to achieve project milestones 
  • Identify gaps in processes, and then work with appropriate parties to develop, and implement solutions 
  • Ensure the development and use of key project management tools, metrics and team meeting logistics and documentation, to enhance project delivery and information dissemination to the broader program team 
  • Facilitate short-term and long-range planning activities for CMC/Technical Operations for assigned projects 

Education and Experience: 

  • Bachelor’s degree in engineering, life sciences or related field, PMP Certification preferred
  • A minimum of 2-5 years of experience in the biopharmaceutical/pharmaceutical industry Previous experience in cell and gene therapy preferred. 
  • Experience in CMC project management of clinical or commercial pharmaceutical products, and experience managing CDMOs/third parties for process development and cGMP manufacturing. 
  • Knowledge of biotechnology/pharmaceutical product development process including technical transfer, manufacturing, stability studies, analytical development, regulatory filings, and clinical/commercial operations. 

Skills/Abilities: 

  • Ability to work independently and successfully in a matrix environment. Prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
  • Strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of an organization. 
  • Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Visio, Outlook). Experience with other PM tools a plus (e.g. Primavera, OnePager, Kidasa, etc.). 
  • Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective. 

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Sudbury, MA

Travel: Available to travel both domestically and internationally (10-15%)

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All resumes submitted by search firms/employment agencies to any employee at Allena via email, the internet or in any form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

 

Files must be less than 2 MB.
Allowed file types: txt pdf doc docx.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.