Senior Formulation Scientist, LNP In Vivo Platform - Editas Medicine

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world.  Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.  

Why Choose Editas?

At Editas Medicine, we’re a team of courageous problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!

Decoding The Role:

Editas is 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 need to 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.

Characterizing Your Impact:

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 the patient needs
• 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 for design and execution of formulation studies supporting both RTO and Process Development, coordinating analytical testing and evaluating stability data to finalize formulation composition
• Create Partnership 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 
• 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
• Assure 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 the 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

Requirements

The Ideal Transcript:

To thrive in this role, you’ll need:

Qualifications

• Advanced degree in scientific discipline and 8+ years of experience in formulation development Proficiency with regulatory information management systems, including Veeva RIM is required
• Expertise with biologics formulation and drug delivery, including cell and gene therapy and mRNA LNP formulations
• Experience in regulatory filings with IND/IMPD/CTA period of product life-cycle and collaborate with full CMC Team to support clinical development in the DOQ organization
• Thorough understanding of industry guidance, knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle
• Strong technical leadership with the ability to apply sound judgement and effective decision making to drive the strategic objectives of the DOQ organization and influence the broader business as a whole
• Travel to support technical transfer efforts, as required.
• Ability to routinely (approximately 35%) travel to manufacturing facilities.

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.

Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.