Senior Specialist Small Molecule CMC Compliance

3 days ago

Boston, Massachusetts, United States Hydrogen Group Full time

Senior Specialist, Small Molecule CMC Compliance

Boston, MA (remote after training)

Schedule:
Standard Office Hours

Duration:
6-Month Contract (with potential extension)

Pay:
$62-67/hr

Our client is a global biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapies for serious diseases.

In this role, you will support the principles and application of Good Manufacturing Practices (GMP), Quality Assurance, and regulatory compliance within the Small Molecule CMC Compliance team. You will coordinate the delivery of Annual Product Reviews (APRs) and contribute to various compliance and continuous improvement initiatives.

Key Responsibilities:

  • Coordinate the development and delivery of Annual Product Reviews (APRs) for all commercial products.
  • Collaborate with subject matter experts (SMEs) to define scope, author content, and finalize APR documentation.
  • Author key report sections such as Purpose, Executive Summary, and Conclusions.
  • Identify appropriate Corrective and Preventive Actions (CAPAs) and ensure timely approval and archiving of reports.
  • Support quarterly quality trending activities for commercial products manufactured internally and at Contract Manufacturing Organizations.
  • Represent Quality in cross-functional working teams, applying strong communication and collaboration skills.
  • Contribute to continuous improvement initiatives within the Quality organization.

Knowledge, Skills, and Competencies:

  • Demonstrated experience facilitating and authoring APRs or Annual Product Quality Reviews for commercial pharmaceutical products.
  • Proven ability to manage multiple projects and deliver within defined timelines.
  • Effective collaboration and communication skills across cross-functional teams and stakeholders.
  • Strong written and verbal communication skills, with the ability to convey complex information clearly.
  • Working knowledge of current Good Manufacturing Practices (cGMPs) in a pharmaceutical environment.
  • Proficiency in event investigations, Root Cause Analysis (RCA), and CAPA processes.
  • Ability to thrive in a fast-paced environment while meeting quality and timeliness objectives.

Preferred Experience:

  • APR and Veeva systems experience.
  • Exposure to cross-functional environments with large stakeholder groups (30+).

Education & Experience:

  • Bachelor's degree in a scientific or allied health field (or equivalent).
  • Minimum of 2 years of relevant experience, or an equivalent combination of education and experience.

  • Scientific Editor, Small Molecule Modalities

    1 day ago

    Boston, Massachusetts, United States Drug Hunter Full time

    Drug Hunter ) is a subscription pre-competitive intelligence platform for biotech/pharma R&D scientists that empowers them to discover the medicines of the future. We're proud to support teams at 200+ of the world's leading biotech and pharma companies.We are seeking a rigorous, investigative Scientific Editor with excellent research and communication skills...

  • Director, Regulatory Site CMC

    1 week ago

    Boston, Massachusetts, United States Takeda Full time $174,500 - $274,230

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Senior Director, Regulatory CMC

    3 days ago

    Boston, Massachusetts, United States PepGen Full time

    PepGen is at an exciting time in our development. This role is for a motivated and team-orientated individual who flourishes in an environment where they can help lead and shape our future.As an integrated member of the PepGen Team you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the development and life cycle...

  • Product Complaints Quality Manager

    5 days ago

    Boston, Massachusetts, United States Planet Pharma Full time

    Job DescriptionGeneral Position Summary:The Product Complaint Manager is responsible for supporting the Product Complaint Quality System. This role will support quality activities associated within the Small Molecule, Biologics, Device CMC Compliance team and will partner with various internal and external cross-functional teams including Global Patient...

  • Director, Regulatory Affairs, CMC

    4 days ago

    Boston, Massachusetts, United States Xenon Pharmaceuticals Inc. Full time

    Who We Are:Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.What...

  • Senior Director, Supply Chain

    2 weeks ago

    Boston, Massachusetts, United States Rapport Therapeutics Full time $200,000 - $240,000 per year

    When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we're doing this...

  • Senior Director, Supply Chain

    4 days ago

    Boston, Massachusetts, United States Rapport Therapeutics Full time $250,000 - $270,000

    When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we're doing this...

  • Director, Global Regulatory Affairs CMC

    4 days ago

    Boston, Massachusetts, United States Takeda Pharmaceuticals Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Director, Global Regulatory Affairs CMC

    4 days ago

    Boston, Massachusetts, United States Takeda Full time $174,500 - $274,230

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Executive Director, Regulatory Affairs

    7 days ago

    Boston, Massachusetts, United States Vivid Resourcing Full time

    Job Title:Executive Director, Regulatory Affairs (Consultant)Location:BostonIndustry:Biotech / Pharmaceutical InnovationType:RemoteAbout the OpportunityWe are seeking a distinguishedExecutive Director–level Regulatory Affairs Consultantto partner with our leadership team and guide regulatory strategy across a diverse and innovative portfolio. This role is...