Senior Manager, Cellular Process Development
Editas Medicine, United States
Job Description
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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 many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
Key Responsibilities amp; Accountabilities:
- Manage teams collaborating with Research to transfer processes into PD.
- Performing process development and optimization.
- Manage collaboration with AD to generate data to support formulation studies, stability studies, and characterization of drug substance and/or drug product.
- Ensure the teams document all experimental work, supporting information, and data appropriately in an electronic lab notebook (eLN) or batch record in a timely manner.
- Manage the compilation and presentation of data to program teams. Participate in program teams, as necessary.
- Manage the authoring and review of batch records, work instructions, technical reports, statements of work and supporting procedures.
- Manage process technical transfer, including generating supportive documentation, training, and technical support to Manufacturing or contract manufacturing organizations.
- Manage and actively participate in, as required, generating reference standards, lead stability samples, forced stability samples, toxicology lots, non-human use (NHU) engineering run lots, and clinical manufacturing run lots, as appropriate.
- Author, review, and provide technical expertise on processes during the preparation of CMC-related regulatory filings for engineered cell medicine programs.
- Support Quality with required data, technical assessments, and expertise, including contributing to management reviews, material specifications, change controls, CAPAs, deviations, stability plans, specifications, OOS results, comparability assessments, and process validation.
- Other responsibilities as required.
Requirements
Knowledge, Skills amp; Capabilities:
- Experience with applicable cellular manufacturing processes.
- Experience with iPSC and or NK manufacturing processes highly preferred.
- Experience related to the development and/or technical transfer of GMP processes for cellular therapies.
- Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for CGMP operations.
- Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors.
- Experience building and managing teams effectively.
- Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment.
- Strong verbal and written communication skills.
- Strong leadership skills.
- Understanding of product development life cycle and stage gates from research to development to commercial operations preferred.
Education amp; Relevant Work Experience:
- PhD (preferred) in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 5+ years of relevant experience, MS with 8+ years relevant experience or BS with 10+ years of relevant experience
Physical amp; Travel Requirements:
- Some travel required, lt;20%.