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Director/Sr Director of Manufacturing, Science, and Technology

Company: Center for Breakthrough Medicines
Location: King Of Prussia
Posted on: January 16, 2022

Job Description:

Center for Breakthrough Medicines is seeking a highly motivated Director of Manufacturing Science and Technology (MSAT). Reporting to the Head of Tech Transfer, the Director of MSAT position plays a leading role in troubleshooting advanced therapy manufacturing processes and establishing process robustness and late-stage clinical manufacturing strategies. The Director of MSAT will lead a team of scientist/ engineers responsible for technical support for GMP manufacturing, investigations for process related issues and implementation of process changes to enable seamless transition from clinical to commercial operations. This position involves close collaboration within Tech Transfer Leads, Process Development, Manufacturing/Operations, Quality Assurance, Regulatory groups. This position requires strong technical expertise in advanced therapy (cell and/or gene therapy) manufacturing processes.
Primary Responsibilities:
Establish and lead an MSAT team within Process Development at Center for Breakthrough Medicines
Serve as lead subject matter expert in advanced therapy manufacturing sciences
Provide technical review of clinical manufacturing batch records, SOPs, deviations, and investigations
Participate in regulatory and internal audits.
Design and oversee experiments in collaboration with Process Development, Analytical Development, and other teams to support investigations and process improvements for manufacturing
Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and robustness for cell and gene therapy manufacturing processes
Identify and implement process improvements for cell and gene therapies during early and late-stage clinical manufacturing and associated technical transfers
Collaborate with Process Development, Manufacturing, and Analytical Development on actions necessary in preparation for late-stage trials and filing of BLA
Support production related investigations, ensuring compliance with internal standards and regulatory requirements by providing technical analysis to support impact assessments and investigations
Build strong relationships with stakeholder groups to create a culture of high performance
Education & Experience:
B.S./M.S./Ph.D. in Biochemistry, Chemical/Biomedical Engineering or Biology/Immunology discipline or equivalent --- 12+ overall years' experience with 5+(Ph.D.) 10+(BS/MS) years relevant industry experience in of Late-stage Process Development or MSAT with management responsibility
Thoroughly understand the cell and gene therapy manufacturing processes along with associated equipment and technologies to support issue resolution for manufacturing operations
Strong understanding of global regulations, regulatory filings, and validation/qualification requirements
Familiar with cell therapy supply chains and manufacturing methods
Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements
Experience in effectively managing scientific groups and projects
Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment
Demonstrated skill in leading project teams tasked with resolving complex production related issues

Keywords: Center for Breakthrough Medicines, Philadelphia , Director/Sr Director of Manufacturing, Science, and Technology, IT / Software / Systems , King Of Prussia, Pennsylvania

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