Senior Director, Manufacturing Science & Technology - 2436
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.
Editas is seeking an experienced and highly motivated leader to build Manufacturing Science & Technology to support late stage clinical and commercial manufacturing of CRISPR gene editing medicines. The successful candidate will build and lead a team of engineers and scientists to provide advice and guidance on manufacturing technologies, initiatives and strategy for continuously improving manufacturing performance. This leader and the team will need to coordinate cross-functionally with Process and Analytical Development, Internal and External Manufacturing, Validation and Metrology, Quality Control and Analytical Technologies (QCAT), Quality Assurance, and Regulatory to support process validation and manufacturing of gene editing components and ex vivo CRISPR gene-edited cell therapies both internally and at Contract Manufacturing Organizations (CMOs). This role requires strong technical writing skills and first-hand knowledge of the industry guidance’s related to process validation, process monitoring, and technical transfer.
- Build and lead a team of engineers, scientists, and associates to develop technical transfer, process qualification, and continuous process verification strategies and programs and provide oversight for programs for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally or at CMOs
- Establish and maintain procedures, business processes and tools for technical transfer, process qualification, and continuous process verification using industry best practices and adhering to industry standards
- Facilitate technology transfer into the internal late stage clinical and commercial manufacturing facility and at CMOs
- Develop process control strategies based on identified critical material attributes (CMAs)and critical process parameters (CPPs) with the responsibility to identify and provide technical justification for the use of raw materials with the required CMAs to support secondary or alternative suppliers
- Lead or support multi-disciplinary process validation teams, collaborating effectively cross-functionally to negotiate scheduling and commitment of resources outside the department required for validation projects
- Establish and maintain the Validation Master Plan (VMP) for manufacturing process, aseptic process, and shipping validation, working cross-functionally with key stake holders and responsible functions to ensure the defined VMP activities are executed and maintained and all supporting documentation is complete and accurate
- Provide technical support, advice and guidance on manufacturing technologies, initiatives and strategy for continuously improving manufacturing performance for late stage clinical and commercial supply
- Responsible for complex manufacturing investigations and providing technical evaluations for deviation investigations, corrective and preventative actions, and change controls
- Provide process knowledge and expertise to support equipment performance qualifications
- Author, review, and provide strategic guidance, technical expertise, and process knowledge support during the preparation of regulatory filings
- Represent the department during audits, pre-approval inspections, meetings, and teleconferences regarding process validation with regulatory agencies and provide related responses to inspections and audit observations
- Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and promotions, identifying opportunities and provide the means for employees to pursue career growth
- Other duties as required