Advanced Formulation Scientist for Gene Editing Innovations

6 days ago

Cambridge, Massachusetts, United States Editas Medicine Full time

At Editas Medicine, we're at the forefront of pioneering innovative gene editing technologies to transform the future of medicine. Our mission is to harness the power and potential of CRISPR/Cas12a and CRISPR/Cas9 genome editing systems to develop transformative, durable, precision genomic medicines for people living with serious diseases worldwide.

We're seeking a highly experienced and motivated Senior Formulation Scientist, LNP In Vivo Platform to provide expertise and guidance for formulation, container closure, and packaging for gene editing components and CRISPR gene editing medicines. This individual will collaborate cross-functionally within Technical Development as well as with Technical Operations and Quality in the DOQ department and the Development Medical Organization (DMO) and the Research and Translational Organization (RTO) to support formulation, fill, and finish activities and formulation development across the pipeline.

This role requires strong technical writing skills and first-hand knowledge of formulation and drug delivery. As the Senior Formulation Scientist, LNP In Vivo Platform, you will:

  • Provide highly skilled and effective communication across Research and Science teams while elaborating challenging topics and demonstrating manufacturing experience to teams to create formulation and delivery systems that influence manufacturing processes to meet patient needs.
  • Be responsible for formulation, container closure, fill, and finish, and packaging for gene editing components and gene-edited therapeutics.
  • Troubleshoot and problem-solve unresolved or new formula issues.
  • Lead design and execution of formulation studies supporting both RTO and Process Development, coordinating analytical testing and evaluating stability data to finalize formulation composition.
  • Create partnerships connecting teams including RTO to Clinical Research to DMO to Technical Development to CMC to Regulatory (IND, BLA) through commercialization by developing drug product formulations early in the research process and packaging suitable for clinical development and commercialization, meeting the needs of the patient community.
  • Be responsible for all formulation-related CMC documents and associated regulatory filings.
  • Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, QbR, etc.
  • Prepare/review specifications for drug products and packaging components, etc.
  • Support the manufacturing of exhibit/submission batches per regulatory requirements.
  • Support technology transfer for manufacturing processes from laboratory scale to production scale.
  • Work with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc., to expedite the development and approval of new products by FDA.
  • Ensure that all formulation activities are documented in electronic laboratory notebooks and reports as per company procedures.
  • Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality.
  • Actively participate in obtaining patents for products, processes, or equipment.
  • Communicate with outside vendors and laboratories.
  • Provide technical assistance/support for other departments as needed.
  • Make scientific presentations and communicate essential information to employees within the department and/or within the company.
  • Author, review, and provide strategic guidance, technical expertise, and formulation knowledge during the preparation of regulatory filings.
  • Represent the department during audits, pre-approval inspections, meetings, and teleconferences regarding formulation, packaging, and container closure with regulatory agencies and provide related responses to inspections and audit observations.

Earn an Estimated $120,000 - $180,000 Per Year Salary Based on Location and Experience. Benefits include Blue Cross Blue Shield PPO Medical Plan, 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 flexible Paid Time Off policy.

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