Beam Therapeutics
Director, Regulatory CMC
Cambridge, MA · Director
Sponsorship not specifiedDetected 2 days ago
ComplianceSupply ChainGMPCRISPRLeadershipCommunicationTime ManagementWriting
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.
- To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities.
- This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.
Responsibilities
- Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/ex-vivo and in-vivo therapies.
- Develop and proactively communicate regulatory CMC strategies, risks and key issues in an evolving regulatory landscape.
- Act as the regulatory CMC lead and department representative in matrix teams for development programs.
- Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation.
- Plan and manage activities for the preparation of high quality CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, scientific excellence, accuracy, source information traceability, and consistency with related filings in accordance with program timelines.
- Providing critical review of detailed scientific information described in CMC documents and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Develop regulatory processes and procedures to support CMC components of regulatory submissions.
- Support the creation and maintenance of CMC submission templates and dossier standards.
- Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.
- Develops and maintains collaborative partnerships with key internal and external stakeholders.
Requirements
- BS degree in a scientific/engineering discipline.
- Experience with cell and gene therapy and/or lipid nanoparticles is desirable.
- Comprehensive knowledge of regulatory (FDA.
- with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
- Strong experience with CTD format and content regulatory filings.
- ability to communicate complex issues in a succinct and logical manner
- Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
- Typically 12+ years of in the biotech industry with 9+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) with direct technical writing experience for IND/CTA/MF and BLA/MAA submissions.
- Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines
- Excellent organizational, written/oral communication, and time management skills
- strong listening skills.
- flexibility in responding to changing priorities and/or unexpected events.
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Nice to have
- Diverse experience including biologics in the cell therapy space, drugs, and international filings preferred.
Benefits
- Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation.
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