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. 

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.

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.

Administrative Assistant/Office Coordinator

Description

Allena Pharmaceuticals is seeking an assertive, self-motivated and proactive professional to provide administrative support to our Clinical and Chemistry Manufacturing & Controls functions. In addition, this role will support office management for our Sudbury and Newton offices.

Who are we looking for?

  • We’re looking for an enthusiastic administrative assistant who is also willing take on office management support

What are we looking for?

  • Leading the way:  A creative and learning-agile administrative leader, willing to go the extra step
  • 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?

  • Impact: this role by supporting others will have an immediate impact on our employees daily life
  • 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:  

  • Provide administrative support to Clinical and CMC functions including calendar management, travel, conference registrations, expenses and point of contact for onsite and remote staff. 
  • Back up support to the Executive Assistant.
  • Working as a member of the administrative team, assist with company events and projects. 
  • Maintain Sudbury office space, including organizing common areas (conference rooms, kitchens & printer areas). 
  • Order office & kitchen supplies for Sudbury and Newton offices, review and approve invoices for payment.  
  • Maintain vendor relationships – building maintenance, appliance repairs, cleaning services, shredding services, water coolers, etc. 
  • Manage Iron Mountain offsite file storage for Allena. 
  • Maintain filing system for legal contracts and agreements. 
  • Prepare FedEx shipments and receive deliveries/mail for Sudbury location. 
  • Update phone lists as new hires join Allena. 
  • Manage and oversee Allena emails from Allena website and forward to appropriate staff.  
  • Manage and oversee voicemails from Allena main phone line and forward to appropriate staff.  

Skills/Abilities:

  • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands. 
  • Requires strong attention to detail in proofing materials, establishing priorities, scheduling and meeting deadlines.
  • Excellent written and oral communication skills.
  • Ability to recognize opportunities/gaps/obstacles, apply analytical and creative thinking to address issues or find innovative solutions and see it through to completion by taking ownership and accountability.

Competencies:

Collaboration: Fosters and uses collaborative relationships among team members and between teams to facilitate the accomplishment of work goals. Involves others in discussions, decision making and planning, and credits them for their contributions and accomplishments. Regularly communicates with others on the team and within organization with the goal of fostering enthusiasm, mutual trust, candor and respect.

Adaptability: Responds resourcefully, flexibly and positively when faced with new challenges, transitions and demands. Actively & positively seeks to find solutions to challenging problems without losing sight of the ultimate objective or vision. Moves forward productively and optimistically under conditions of change and uncertainty. 

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

Execution: Drives towards high quality results, continually monitoring progress against objectives. Understands and promotes assignment of authority and accountability, and alignment of efforts across teams and functions. Addresses problems or misunderstandings and drives changes necessary to achieve business objectives. Conveys a strong sense of urgency around continuous improvement and follow-through for improving business performance. 

Education and Experience:

  • Experience (2-4 years) working in a fast-paced office environment; experience in office management a plus, but not required.
  • Prior experience working in a pharmaceutical company is highly desired. 
  • Advanced skills in Microsoft Office 365: PowerPoint, Word, Excel, Publisher, Outlook, OneNote, Access. Adobe Photoshop is a must.

Location: Sudbury (primary) and 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.

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.

Clinical Scientist

Description

The clinical scientist is a key member of the clinical development team and is a major contributor to the development and execution of the clinical strategy for our development programs. The successful candidate will interface with the clinical development team to provide scientific and medical expertise to current and future clinical programs, and with medical affairs and business development (including investor relations) to provide data-driven scientific and strategic inputs.

Who are we looking for?

  • Energetic individual who will work with the Clinical Development team contributing to a variety of novel projects and is interested in a laboratory centric career 
  • Must have 3+ years of laboratory experience supporting drug development in a laboratory environment.
  • Leading the way:  A learning-agile and strategic scientist 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 looking for?

  • A creative and focused (attention to details is a must) 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.
  • Excellent communication and presentation skills both written and verbal.

What are we offering?

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

Responsibilities:

  • Contribute to the design and execution of assigned clinical study(ies) in close collaboration with lead study MD and Clinical Operations, and for earlier stage assets, with non-clinical experts, to include safety oversight, trial conduct in accordance with protocol, review of emerging data, etc. 
  • Contribute to and/or lead, as relevant, the preparation of documents including protocols and protocol amendments, preparation of statistical analysis plan(s), preparation of abstracts/posters/manuscripts, and presentations, collaborating with internal and external contributors; write original content as appropriate. 
  • Participate in the review, analysis, interpretation and presentation of accurate study results, including preparation of investigator brochure, annual safety reports, clinical study reports and other documents associated with regulatory submissions. 
  • Build deep knowledge of the therapeutic area(s) relevant to Allena, including current medical practice, existing Allena development programs and study results, competitive intelligence, etc, in order to effectively support Medical Affairs and Business Development with data and information requests.
  • Undertake literature searches and summaries; remain up to date with scientific advances; maintain or oversee maintenance of Allena electronic library. Support investor relations initiatives in providing competitive landscape summaries/briefings.
  • Provide support for Advisory Board meetings, Allena presence at national and/or regional scientific meetings, investigator meetings, etc, including preparation and/or delivery of presentations; working closely with relevant stakeholders. 
  • Cultivate and/or support relationships with external partners such as clinical investigators, clinicians, and scientists in support of trial execution and business development
  • Other responsibilities as they evolve over time. 

Education and Experience: 

  • PhD in the life sciences.  Master’s degree in the life sciences considered if extensive relevant work experience as a clinical scientist with demonstrated ability to work independently.
  • Experience (3+ years) working as a clinical scientist within a pharmaceutical/biotechnology company or other relevant role managing data and document preparation within the life sciences.

Skills/Abilities: 

  • Personal drive and confidence to act as SME to provide scientific and medical expertise to current and future clinical programs, and with medical affairs and business development to provide data-driven scientific and strategic inputs.
  • Innovative and collaborative style.
  • Proven success interfacing with clinical development teams. 
  • 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: Newton & Sudbury, MA

NOTE: This role could be 100% remote for the right candidate.

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.

Senior Director, Process Technology

Description:

The Sr. Director of Process Technology is a highly visible role. He/She 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/Sr Director of Process Technology 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 Sr. Director of Process Technology 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:

  • Leading the way:  A ‘hands-on’ and strategic PD professional willing to challenge the status quo and provide creative solutions to identified challenges
  • 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
  • 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

Education and Experience:

  • PhD, MS or a BA/BS and equivalent relevant experience: 8-12+ years of experience in large-molecule, biologics-related Process Development
  • 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

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

When You Join Allena You Will Have:

  • Free parking, Newton location reachable by public transportation (Green Line)
  • Customized and competitive health coverage including medical offered through BCBS (HMO/PPO), dental, and vision
  • Flexible Spending Accounts for medical and dependent care expenses
  • Eligible from the first day for 401K with 100% match of the first 4%
  • Robust package of Allena paid insurance coverage, including life insurance, short-term and long-term disability
  • 15 days of vacation and 5 personal days per year, in addition to 13 company holidays and 2 floating holidays
  • Winter Break: Allena is closed for a Winter Break between Christmas and New Year

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 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.

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