GMP Manufacturing Specialist III

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.
The GMP Manufacturing Specialist will collaborate with the R&D Process Development group to develop manufacturing processes to support production of cell therapeutics for pre-clinical studies and human clinical trials. The Manufacturing Specialist will support 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. Duties will include raw material ordering, inventory management, raw material preparations (e.g. media, buffers etc.), assisting in cell manufacturing process, completing and compiling GMP documents that are necessary for ensuring compliance with applicable U.S., Canadian and global standards.Responsibilities:

Work with the Process Development group to support the development of manufacturing processes for expansion and differentiation of PSCs; support technology transfer of manufacturing processes to internal and external cGMP manufacturing teams.

Participate in required cGMP training activities, including training on required SOPs and manufacturing batch records. 10%

Prepare protocols for aseptic process qualification studies and process engineering runs. Provide manufacturing support for validation activities.  Manage protocol deviations to closure.   5%

Create or revise manufacturing SOPs and training materials.  Execute OJT with new employees 10%

 Manufacture Cell Drug Substance and Product for pre-clinical and clinical studies by performing aseptic processing in a cleanroom environment while executing on approved batch records. 

Activities include:

Pre/Post Area clearance

Equipment cleaning

Minor preventive maintenance

ISO7/ISO 5 gowning (60%)

Work with Quality Assurance to ensure completion of all associated documentation to support cGMP manufacturing, including batch record review, equipment records, minor/major/critical deviations, CAPA, change control, and OOS. 15%

Support Quality Assurance and Quality control with investigations as needed. 

Requirements:

B 6+ or M 4+ or PhD 0+ years

Experience in cGMP manufacturing with hands-on experience in cell therapy production and aseptic manufacturing techniques

Experience in mammalian cell culture required. Experience in PSC culture and differentiation techniques is highly desirable

Experience in writing SOPs and validation protocols for equipment and manufacturing processes is highly desirable

Experience with Good Documentation Practices is required. Experience reviewing cGMP documentation is highly desirable

Excellent written and oral communication skills and the ability to work in a fast paced, dynamic team environment is required

Expertise using MS WORD, Excel, and database programs. Experience in working with an eQMS and/or LIMS is also desirable

Must be available to work weekends. 

Please note this position will be working in Hopkinton, MA at a Partner's manufacturing facility.
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BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.
Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics
Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace.  Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.