Principal Specialist, Quality Assurance Operations

3 weeks ago

Cambridge, United States Editas Medicine Full time
Job DescriptionJob Description

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Editas is seeking a cooperative, highly motivated and experienced quality professional to support internal GMP manufacturing operations. This position will be responsible for Quality Operations support of internal clinical manufacturing at the Editas Waltham and Devens GMP manufacturing facilities as a member of the Quality Operations team. Specific responsibilities include but are not limited to Quality support/oversight and leading initiatives related to: tech transfer and facility start-up, floor operations, MBR and SOP generation/revision, record review, controlled document generation, batch release, training, materials management, equipment management, and maintenance at the Editas Waltham and Editas Devens GMP manufacturing facilities.

Key Responsibilities:

As the Principal Specialist, you will be responsible for:

  • Support Editas’ clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of the Quality Operations team.
  • Provide Quality oversight of start-up activities for a new facility and equipment as well as process commissioning & qualifications.
  • Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met.
  • Support QA on the floor activities including line clearance and QA process touchpoints as required.
  • Support clinical lot disposition preparation and review.
  • Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).
  • Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
  • Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
  • Independently handle complex investigations in cross-functional areas.
  • Exercise good judgment in issue identification and timely escalation to management.
  • Exercise judgment in resolving moderate to complex quality issues.
  • Act as QA liaison to site personnel to provide quality system expertise to help identify solutions and ensure compliance to cGMP.
  • Plan and execute work independently and consult with supervisor as needed.
  • Supports the organization in maintaining inspection readiness.
  • Provide QA oversight for product Shipments.
  • Assist in internal and external audits as required.

Requirements

Required Qualifications:

The ideal candidate will possess:

  • Bachelor’s/Master’s in Biology, Chemistry or other life science and 8+/6+ years respectively of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment.
  • Experience supporting Quality Operations required.
  • A working knowledge of cGMP requirements in clinical or commercial biologics required.
  • Excellent verbal and written communication skills required.
  • Understanding of regulatory guidance on cell and gene therapy products.
  • Expertise working within cGMP compliance and providing GMP documentation.

Preferred Qualifications:

Additionally, candidates with the following attributes are preferred:

  • Experience with both early and late phase clinical manufacturing. Experience with new product introductions or facility start-ups. Experience providing quality oversight for QC.
  • Experience in both clinical and commercial or late stage clinical preferred.
  • Prior experience with mammalian cells and/or gene therapies preferred.
  • Demonstrated experience with mammalian cells and/or gene therapies preferred.
  • Experience with cell culture, single use technologies, and aseptic processing.
  • Experience with GMP’s in a working manufacturing environment.
  • Investigational skills including Root Cause Analysis and Product Impact Assessments.

Physical & Travel Requirements

  • Ability to gown into a cleanroom.
  • Ability to support a morning or evening shift schedule.
  • Some travel may be necessary.

Benefits

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.

Fostering Belonging. Fueling Innovation. Transforming Lives.

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