GMP Manufacturing Senior Specialist
BlueRock Therapeutics, Canada
Job Description
Who is BlueRock?
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
What Are We Doing?
Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.
Description of Position:
The GMP Manufacturing Senior Specialist will support the development of BlueRock’s therapeutic pipeline with a focus on leading and performing aseptic GMP cell manufacturing and/or cell suspension formulation processes at BlueRock’s facilities, at collaborating clinics, but may also include development and tech transfer or performing GMP manufacturing and/or oversight.
The Manufacturing Senior Specialist will collaborate with the GMP Team (Manufacturing, QA and QC) and Process Development groups to develop and provide aseptic GMP formulation processes and products for non-clinical and clinical application of cell therapeutics at BlueRock’s facilities or at collaborating clinics. The Manufacturing Senior Specialist will lead technology transfer of manufacturing processes internally and to external collaborators and will be responsible for executing cGMP process qualification and validation studies as well as cGMP production activities. Other duties may include oversight of manufacturing activities, raw material ordering, inventory management, raw material preparations (e.g. media, buffers etc.), completing and compiling GMP documents and regulatory submissions that are necessary for ensuring compliance with applicable U.S., Canadian and global standards.
This position may include travel 25% to 35% to support ongoing clinical studies for direct formulation of the cell therapy at collaborating clinics. The remainder will be focused on development, execution or oversight of GMP cell therapy manufacturing processes and products.
Responsibilities:
- Lead, develop and perform aseptic formulation processes of GMP cell therapies within BlueRock’s facilities or collaborating clinical setting and/or tech transfer formulation procedures and equipment for use within cell therapy clinics.
- Work with cross-functional teams to support the development of manufacturing processes for expansion and differentiation of cell therapies; perform technology transfer of manufacturing processes to internal and external cGMP manufacturing teams.
- Produce cell Drug Substance and Product for non-clinical studies and human clinical trials by procuring raw materials, preparing manufacturing facility/equipment and documentation, and executing the approved procedures and batch records; work with Quality Assurance to ensure completion of all associated documentation to support cGMP manufacturing.
- Work with Quality Control to develop in-process testing plans; assist in the development of appropriate analytical methods as needed.
- Project leader, responsible for leading meetings and sending action items, meeting minutes, and agendas; update project timelines and communicate to relevant team members, management, program managers and/or external collaborators.
- Manage and mentor direct reports and other team members
- Support Quality Assurance for cGMP production, in-process testing, and release testing of cell therapies. Work with QA to address quality events including deviations, CAPAs, OOS and other failure investigations as needed.
- Support QA and QC functions for cleanroom operations including review and tracking of equipment records for P