Beam Therapeutics
Associate Director, Product Quality Assurance
Cambridge, MA · Director · Full-time
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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
- Primary responsibilities encompass all aspects of Quality support for GMP operations. Quality oversight will include external GMP operations (ex. CDMOs, CTLs) and internal analytical operations.
- for quality oversight will also extend to support in other areas of Beam that may support early phase GMP activities.
- Responsible for the core interface and relationship with CDMOs and other external partners from a quality perspective.
- Use sound judgement and critical thinking to develop solutions and drive risk analysis and mitigation strategies.
- Create and ensure appropriate quality systems are in place to support analytical testing and product release in a compliant and timely manner and routinely monitor performance to established targets.
- Evaluate facility, procedures, equipment, personnel and processes to ensure that they consistently deliver product that meets all applicable requirements.
- Assure appropriate reviews and approvals for manufacturing and analytical testing records in support of product release.
- Take lead role in organizing and completing investigations, coordinating with other departments involved, and driving closure in a timely manner.
- Provide GxP auditing support for contract service providers.
Requirements
- Bachelors or Advanced degree in a scientific discipline.
- Typically, 10+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality.
- Must have Biologics experience.
- 3+ years of Quality management experience with a successful track record in managing CDMOs as well as internal QA systems in a virtual environment.
- Established expertise and training in GxP systems.
- Evaluate and sign off on compliance documentation as required.
- Typically, 10+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality. Must have Biologics experience.
- Understanding of worldwide requirements of cGMP and quality systems for commercial and clinical products.
- 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.
- Ability to evaluate Quality Systems and drive value added enhancements.
- 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 team building, leadership and management skills.
- Excellent listening, communication and interpersonal skills fostering team spirit.
- Consistent delivery of high quality work at all times.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.