Specialist/Senior Specialist, Product QA

1 month ago

Cambridge, Massachusetts, United States Beam Therapeutics Full time

Company Overview:

Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. 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.

Position Overview:

The Specialist/Sr. Specialist, Product QA will report into the Product QA team and will support cGMP activities at our internal production and testing locations and in our CDMOs/external partners. The position will be critical to the overall build strategy and growth of the Quality organization for Beam as the company grows and evolves from a Research and Discovery company to a broader organization moving products through the clinical pipeline to commercial launch and growth. The Specialist will have responsibility to assure initiatives related to quality and compliance are optimized and executed appropriately in the areas of GMP compliance. The position is based in Cambridge and will also have remote responsibilities at the Beam NC facility. It will support analytical equipment qualification and deviations associated with routine testing. The position will also ensure batch reviews and associated quality processes (e.g., deviations, CAPA, change control, protocols, etc.) are progressed in a compliant and timely manner to maintain cGMP compliance. The candidate will work with cross-functional teams to identify and implement meaningful corrective actions arising from deviations and audit observations. The position will also support Beam's internal groups across the company where quality operations support is required (ex. Quality support in early phase GMP operations that may occur in Beam's internal groups).

Responsibilities:

  • Supports analytical instrument and method qualification, method transfer, and lab investigations as necessary, including review and approval of associated quality records and documentation.
  • Reviews and approves complex manufacturing batch production and analysis records in support of product disposition in accordance with specifications and SOPs.
  • Provides QA guidance and recommendations in a professional and collaborative manner to internal and external stakeholders.
  • Monitors various stages of batch processing at contract partners.
  • Drafts and reviews SOPs and related GMP documents.
  • Reviews and approves quality system records associated with internally and externally produced or tested products (discrepancy reports, investigations, CAPAs, Change Controls, etc.)
  • Provides QA support for incoming materials activities.
  • Provides QA support to contact manufacturing operations (attend meetings, person in plant review and approval of CMO documentation.)
  • Assures change control activities are implemented according to approved plans.
  • Evaluates the effectiveness of CAPAs and other changes.
  • Monitors and trends batch record errors, provides management with quality indicator data, and collaborates with stakeholders to reduce sources of error.
  • Applies strong technical expertise of QA/QC and Manufacturing processes to support development and maintenance of cGMP compliant quality systems.

Qualifications:

  • B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred with 10+ years of relevant experience in a GMP environment with at least 2 years with pharmaceutical quality experience is preferred. Candidates with less than 10 years' experience but have worked in Cell/Gene Therapy are encouraged to apply. Offered level and responsibilities will be commensurate with experience.
  • Working knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of biotech/cell/gene therapy manufacturing, and analytical testing is required.
  • Ability to independently troubleshoots problems and issues; may be called upon to train or assist others.
  • Ability to provide consistently prompt, efficient, dependable, highly skilled service.
  • Demonstration of consistently excellent judgment, quality, accuracy, speed, and creativity.
  • Ability to detect and resolve problems and assist others with problem resolution.
  • Ability to understand, select, and use appropriate risk management and root cause analysis tools.
  • Able to take initiative in making improvement suggestions to promote operational goals.
  • Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
  • Demonstrates solid understanding of strategies and goals and can take part in major parts of projects or provide expert service.
  • Recommends improvements to on-going processes and projects.
  • Facilitates designing processes with Quality built in from the beginning.
  • Identifies and uses good judgement to handle situations that have high compliance risk.
  • Good listening and communication skills.
  • Positive approach.

Location Requirement:

  • This is a hybrid role however; this role requires that the candidate(s) live within a reasonable commuting distance to be on site in our Cambridge location several times per week.

Directions to apply: Submit your resume to

Please list this job title in the Subject of your email. Qualified candidates will be contacted immediately

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