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. 

Senior Director, Clinical Research/Clinical Development

Description

This role reports to and collaborates closely with the Chief Medical Officer. Responsible for leading the global Phase III program for the lead compound in close partnership with Clinical Operations. The Senior Director will engage and establish relationships with the medical and patient communities to inform and execute the Phase III Program while ensuring strategic alignment of internal and external activities.

With other relevant Allena functions will also contribute to developing the strategy for the development of follow-on compounds. This teammate works collaboratively with other Allena functions, including Medical Affairs, Commercial, and Regulatory Affairs.

Who are we looking for?

  • An innovative person who will help Allena’s Clinical/Medical & Regulatory Affairs/Commercial teams in the execution of their goals.
  • MD is required; significant experience in nephrology, urology, rheumatology or endocrinology  preferred
  • Ideally, a minimum of 5 years of pharmaceutical clinical research or other highly relevant clinical research experience (e.g., academic research)

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?

  • Strategic leadership role for overall clinical development for Allena’s ALLN-177 Program
  • 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

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%
  • A robust package of Allena paid insurance coverage, including life insurance, short-term and long-term disability
  • PFMLA fully paid by Allena
  • 15 days of vacation and five personal days per year, in addition to 13 company holidays and two floating holidays
  • Winter Break: Allena is closed for a Winter Break between Christmas and New Year

Responsibilities:  

  • Serve as primary Medical / Scientific leader for the ALLN-177 Program. In that capacity:
    • Develop and implement medical/scientific strategy through strong engagement and learning from medical/KOL and patient communities
    • Participate in site identification and PI engagement, Investigator’s meetings, working closely with clinical operations personnel, CRO, etc.
    • Contribute to the development of Phase III study-related documents and statistical analysis plans
    • Partner closely with Clinical Operations to proactively identify program risks and create and implement mitigation strategies
    • Oversee and participate in ongoing safety monitoring, DSMB activities and the interpretation/analysis of trial results, including laboratory and biomarker data.
  • Oversee and contribute medical/scientific input to the preparation of clinical study reports, Investigational Brochures, statistical analysis plans and ISE, periodic safety update reports, briefing documents, annual reports, IND, BLA and other regulatory including the ISS documents

Skills/Abilities:

  • Proven success working with and effectively supporting cross-functional teams. 
  • We are looking for a leader who embraces and models positive and super collaborative style of work. Please see our leadership competencies below. 

Education and Experience:

  • MD is required; significant experience in nephrology, urology, rheumatology or endocrinology  preferred
  • Minimum 5 years of pharmaceutical clinical research or other highly relevant clinical research experience (e.g., academic research)
  • Knowledge of scientific principles of controlled clinical studies and working knowledge of GCP and FDA/ICH guidelines
  • Demonstrated experience in clinical research and ability to meaningfully contribute to development strategy, critical review of data, generation of research hypotheses, publication, and presentation of scientific information

Ability to travel up to 20-25% of the time

Location: Newton, MA

Competencies:

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. 

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 the organization with the goal of fostering enthusiasm, mutual trust, candor and respect.

Communication: Creates an environment that 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 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. 

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. ​

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. 

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.

Associate Director/Director, Regulatory Affairs

Description

The AD/Director of RA is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration for Allena’s development programs.

Who are we looking for?

  • An innovative person who will partner Allena’s Regulatory Affairs team in the execution of their goals.
  • Ability to work with a small dynamic team

What are we looking for?

  • Ownership:  A partner to jointly own Regulatory focused company’s goals for successful execution 
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Building strong relationships internally and externally to drive results

What are we offering?

  • Strategic role for overall Regulatory development for Allena’s Reloxaliase 
  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites

Responsibilities:

  • Serve as the regulatory lead on multidisciplinary project teams
  • Work with Regulatory management to develop and implement regulatory strategy for assigned projects in all stages of development (pre-IND/pre-CTA through approval and life-cycle management)
  • Author regulatory documents in support of filings including INDs/CTAs, Briefing Materials for Health Authority meetings, Pediatric Plans (US & EU), Expedited Pathway Applications and Marketing Applications
  • Plan, manage and execute regulatory activities, including submission and maintenance of global regulatory filings (FDA, EMA & ROW) to meet strict deadlines
  • Participate as an active team member and provide strategic regulatory advice to project teams as required
  • Work collaboratively on cross-functional teams taking a problem-solving approach identifying regulatory risks with proposals for risk mitigation
  • Work independently with minimal direction and within project teams, committees, etc. to attain group goals
  • Serve as a liaison within internal departments at Allena with CROs and with regulatory program managers at HAs
  • Remain current on Regulatory Intelligence, new guidance documents and competitive information in order to provide fully informed information to teams and development programs
  • Support or lead non-project activities, as needed (i.e. SOP/standards development, organizational initiatives) for regulatory compliance

Education and Experience: 

  • Bachelor's degree with 6 or more years of experience in a Regulatory Affairs role; minimum of 6 years’ experience working in the biotech or pharmaceutical industry
  • RAC certification and/or advanced degree desired 
  • Experience in interfacing with relevant regulatory authorities
  • Experience and knowledge in the preparation of major regulatory submissions e.g., INDs, CTAs, Annual Reports, Safety Reporting, etc.
  • Understanding of regulations and experience in interpretation of guidelines with requisite technical system skills to support global submissions

This Position may require up to 20% travel

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, 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.

Director, Discovery Programs and Portfolio Planning

Description

We are seeking an individual motivated by the opportunity to identify, prioritize, and advance novel oral biologic discovery opportunities to expand Allena’s pipeline of oral enzyme therapeutics.  The candidate will utilize a combination of Allena’s in-house knowledge and external resources, including scientific literature and scientific and medical experts, to identify and evaluate a new disease targets that are most attractive for an oral biologic therapeutic approach in alignment with Allena’s R&D strategy. For the disease targets determined as high priority, the candidate will serve as the scientific lead for enzyme selection and optimization, execution of initial proof-of-concept studies, and assay development. Finally, the candidate will support the cultivation and management of relationships with potential pharmaceutical / biotechnology partners for potential co-development of new oral enzyme programs, including scouting of enzyme candidates that could be considered for in-licensing opportunities

Who are we looking for?

  • An energetic professional who is passionate about Business Development/Discovery Program Management and Execution
  • A resourceful, self-starter and team player with a strong results orientation
  • You can develop trusting relationships to gain support and achieve results at all levels of the organization

What are we looking for?

  • A driven professional who knows how to work and contribute to a dynamic working environment
  • A person who thrives in a small company atmosphere
  • Ability to determine task priority and maintain established deadlines

What are we offering?

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

Responsibilities:

  • Identify and perform scientific evaluation of opportunities for expansion of Allena’s R&D pipeline and oral biologic platform
  • Perform scientific scouting and evaluation of external assets for priority disease targets and contribute to potential in-licensing processes
  • Serve as scientific lead for internal discovery programs for platform expansion, leading  and executing enzyme optimization, proof-of-concept studies, assay development together with all documents preparation for IND filling; 
    • work cross functionally between research PD, CMC , QA and regulatory teams
    • plan timelines and budget
    • prepare scientific presentations and papers
  • Identify external partners for oral biologic platform collaboration opportunities and manage business development processes
  • Monitor competitive landscape in priority disease areas for oral biologic platform expansion and apply scientific findings to Allena’s pipeline and business development objectives  

Education and Experience: 

  • PhD in biochemistry or related field from highly reputable institution
  • Candidates with internship/employment experience in a technology transfer/innovation/licensing office will be considered
  • Demonstrated experience in pharmaceutical/biotech business strategy, portfolio planning, and alliance management
  • Demonstrated experience in management and execution of early-stage research projects from initial idea to proof of concept studies
  • Demonstrate ability to write, prepare and critically review regulatory documents
  • Demonstrate experience in successful management of contract (external) labs 
  • Strong interpersonal skills for collaborating seamlessly with internal stakeholders and external partners
  • Solid organizational skills and experience managing projects efficiently
  • Strong written and verbal communication skills for preparing and delivering presentations to colleagues and senior management
  • Candidate with innate curiosity about biotechnology/pharma industry trends beyond their area of primary focus is highly desirable

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, MA/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, 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.

Scientist, Formulation Development

Description

The Scientist, Formulation Development will interface with a diverse team across CMC, pre-clinical, and clinical to facilitate the development of robust, scalable, and reproducible oral enzyme therapeutics.  The individual chosen will have broad experiences in designing, executing, and leading activities with oral solid dosage formulations (immediate- and modified-release tablets and capsules), from benchtop to scaleup.

Who are we looking for?

  • A creative and focused Scientist able to consistently deliver results to drive projects forward
  • A colleague to join our lab as both an individual and team contributor with opportunities to make an impact 
  • A team member with positive energy who is passionate about asking questions and finding answers
  • A professional with experience establishing and maintaining relationships internally and externally 

What are we looking for?

  • A driven professional who knows how to work and contribute to an everchanging fast paced work environment
  • A willingness to learn new things, adapt to new ways, and passionate about finding answers
  • A person who thrives in a small company atmosphere
  • Ability to determine task priority and maintain established deadlines

What are we offering?

  • Membership within a growing, CARING and collegial organization with a commercializing oral enzyme therapeutic focus
  • Opportunity to embrace autonomy, have an influence, and make an impact on a small team
  • Internal and external facing role with the opportunity to gain knowledge and career development
  • Exposure to pioneering and growth within the PD and CMC teams

Responsibilities:

  • Collaborate with cross functional team members (pre-clinical, Analytical Development, QC, clinical groups, etc.) to define formulation requirements and limitations for early and late-stage assets.
  • Independently and/or in collaboration with Contract Development Manufacturing Organizations (CDMOs) develop phase appropriate oral solid dosage formulations for immediate or modified release.
  • Executes well-designed experiments to define quantitative and qualitative formulation composition.
  • Conduct design of experiments (DoE) studies to identify and investigates key and critical quality attributes to confirm formulation robustness as per ICH Q8.
  • Design and carry out experiments in support of formulation development using traditional solid-state and solution state analytical techniques, including but not limited to UV-Spectroscopy, Dissolution, HPLC analysis, particle size and flow measurements. 
  • Evaluate data, interpret results, formulate relevant and scientifically based conclusions, and write and present technical reports.

Education and Experience: 

  • A PhD or MS in Pharmaceutical Sciences or related discipline with relevant experience in formulation of oral solid dosage forms.  
  • Hands-on experience with typical tablet and capsule manufacturing processes:  blending, wet and dry granulation, compression, in-process controls, and film coating. 
  • Knowledgeable of immediate- and modified-release oral solid dosage forms. 
  • Experience with solid-state properties of excipients and formulations.
  • Knowledge of analytical methods and instrumentation used for the characterization of solution. 
  • Familiar with design of experiments (DoE) and statistical tools to assess formulation robustness.
  • Experienced with form selection/characterization, pre-formulation, and formulation development of scalable oral solid dosage forms.
  • Experience authoring and reviewing development reports. 
  • Ability to succeed both independently and within a cross-functional team.
  • Excellent written and verbal communication skills and ability to influence across multiple functions.
  • Experience working with proteins and spray drying is a plus

This Position may require up to <10% travel

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, 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.

Manager, Supply Chain

Description

The Manager, Supply Chain will interface with a diverse team across CMC, Clinical Operations, and Quality, to enable proactive forecasting of development and clinical trial needs to drive external technical transfer and production activities at all phases.  The individual chosen will be responsible for generating, maintaining, and executing end-to-end supply plans for early stage and late-stage programs and will manage day-to-day production activities; inclusive of providing on-site plant support, when feasible.   

Who are we looking for?

  • A creative, focused, and dedicated Supply Chain professional able to consistently deliver results to drive projects forward
  • A colleague to join our team as both an individual and team contributor with opportunities to make an impact 
  • A team member with positive energy who is passionate about asking questions and finding answers
  • A professional with experience establishing and maintaining relationships internally and externally 

What are we looking for?

  • A results driven professional who knows how to work and contribute to an everchanging fast pace working environment
  • A willingness to learn new things, adapt to new ways, and go with the flow
  • A person who thrives in a small company atmosphere working towards commercialization
  • A strategic mindset with the ability to determine task priority and maintain established deadlines

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
  • Opportunity to support Clinical and Non-Clinical projects and initiatives
  • Opportunities for mentoring and career development 

Responsibilities:

  • Coordinate and manage transportation and logistics for overseas and domestic shipments.
  • Owner of all aspects of the Demand and Operations Planning process; managing supply planning for Drug Substance, Drug Product, and Finished Goods at the program and study level.
  • Collaborate with key stakeholders to gather input (clinical design, enrollment forecasts, production schedule, kitting and distribution etc.) and gain alignment for supply plan execution. 
  • Direct activities to gain agreement/group alignment and communicate the demand and supply plans, potential supply risks, and supply metrics throughout the organization.  
  • Manage both production and distribution orders for labeled CTM to ensure adequate inventory throughout the global clinical depot network.
  • Research and execute on operations for commercial vendors and develop a potential strategy including; CPO and 3PL

Education and Experience: 

  • Degree in Supply Chain or Life Sciences, BS/5+ or MS/3+ years of relevant industry experience.
  • Strong understanding of cGMP/GCP processes and experience with international labeling, shipping, and import/export of clinical supplies. 
  • Experience with technical project management, technology transfer and vendor management. 
  • Familiarization with demand planning tools and IRT/RTSM systems.
  • Excellent written and verbal communication skills and ability to influence across multiple functions.
  • Ability to succeed both independently and within a cross-functional team.
  • Strong organizational and problem-solving skills.

This Position may require up to 20% travel

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, 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.

Quality Assurance Manager/Senior Manager 

Description

The Quality Assurance Manager/Sr. Manager will be primarily responsible for supporting GMP activities of external manufacturing network for Allena’s products and ensuring conformance to Allena’s established quality and compliance requirements. This position reports directly to Director level or above within QA organization.  Primary responsibilities of this position include support for all aspects of process development, clinical and future commercial manufacturing, testing and release of drug substance and drug product, collaboratively partnering with and effectively managing multiple pharmaceutical contract manufacturing sites.  Activities include working directly with Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories (CTL) regarding GMP audits, change management and validation of analytical, process, facility and equipment, batch dispositions and quality issues resolutions such as deviations, OOS/OOT investigations, and Material Review Board decision. 

Who are we looking for?

  • An energetic professional who is passionate about Business Development/Discovery Program Management and Execution
  • A resourceful, self-starter and team player with a strong results orientation
  • You can develop trusting relationships to gain support and achieve results at all levels of the organization

What are we looking for?

  • A driven professional who knows how to work and contribute to a dynamic working environment
  • A person who thrives in a small company atmosphere
  • Ability to determine task priority and maintain established deadlines

What are we offering?

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

Responsibilities:

Quality Assurance 

  • Conduct vendor qualification and audits of selected CMO/CTL in support of GMP supply chain as required 
  • Assist with maintaing audit program including collaborating with external auditors and keeping vendors’ Quality Agreements current
  • Review and approve CMO master batch records, review executed batch records and associated documentation, and perform final disposition for drug substance and drug product release
  • Support Allena contract manufacturing sites during batch production, ensuring unexpected events are handled compliantly 
  • Represent Allena QA to support facility and equipment qualification, cleaning and process validation, and Pre-Approval Inspection at contract manufacturing sites 
  • Review and approve standard operating procedures, facility and equipment qualification documents, and process validation protocols and reports
  • Review and approve documents associated with deviations, investigations, OOS/OOT results, and CAPA action plans 
  • Review process development and analytical technical reports and verification/review of associated data as needed
  • Assist in authoring and review of general QA/QC SOPs
  • Initiate/review action reports or deviation reports for any applicable nonconformance
  • Build on relationships with Quality Assurance partners at CMOs and CTLs ensuring quality issues are tracked and resolved in a timely manner
  • Track and trend batch execution at CMOs, providing periodic updates to Management – alignment to target Turnaround Times and Disposition dates, number of comments and deviations per batch 
  • Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner 
  • Engage in activities to continuously assess and improve lot review and disposition processes  
  • Support review of CMC sections for regulatory filings including but not limited to IND’s and BLA

Other

  • Interact with internal and external auditors as well as external customers or functional groups.  May be required to act as spokesperson or subject matter expert on behalf of company.
  • Responsible for providing continued evaluation of current processes and procedures for the Quality Assurance program and recommending improvements to management.
  • May recommend cost improvements and provide advice on routine operational procedures as related to Quality Assurance

Education and Experience: 

  • B.S. or M.S. in Chemistry or other related scientific field
  • Minimum of 7 years of work experience in pharmaceutical QA and/or QC required
  • ‪Experience in GMP audits, clinical and commercial quality operations 
  • Good working knowledge of relevant regulations and guidance (i.e., ICH, GMP, etc) 

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, MA/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, 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.

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