Beam Therapeutics

Associate Director, Product Quality Assurance

Cambridge, MA · Director · Full-time

Sponsorship not specified$185k-$225kDetected 65 days ago

Product StrategyCustomer SupportGMPFDA RegulatoryCRISPRCommunicationCollaboration

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.

Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments.
Drives and takes action on Phase Appropriate Quality strategy for Beam's products.
Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation.
Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc.
Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL.
Support clinical to commercial analytical control strategy.
Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.).
Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations.
Supports expiry extensions in collaboration with QC.

Bachelors or Advanced degree in scientific discipline.
Ability to influence without direct authority.
12+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role.
Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
Ability to develop into a primary PQL for Beam programs.
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions.
Experience interacting with regulatory health authorities at pre- and post-approval inspection.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Excellent listening, communication and interpersonal skills fostering team spirit.
Consistent delivery of high-quality work at all times.
Candidates are expected to come onsite to our Cambridge, MA site 1-3 days per week.

Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.