Senior Director - Manufacturing - Cellerant Therapeutics - San Francisco

Job description
Responsible for overseeing the execution of cGMP manufacturing of cellular therapy and monoclonal antibody products, all supply chain related activities, and management of all subcontractors including recruitment and management of blood collection centers. Functional responsibilities include scheduling, budgeting, working with manufacturing staff and subcontractors, interfacing with the company preclinical, clinical development, quality and regulatory staff, representing the company at meetings with the FDA and other government agencies as required. Works with Research, Process Development, Manufacturing, QC and QA groups to efficiently transfer pilot scale development processes to manufacturing groups for the production of Stem Cell Therapies and Monoclonal Antibodies and manage experimental activities required to resolve manufacturing issues. Duties and responsibilities include but not limited to:
Directs all aspects of manufacturing operations.
Provides oversight and ensure robustness of technology transfer of manufacturing process to CMOs.

Responsible for sourcing and negotiating pricing/supply agreements with raw material manufacturers and all external vendors.
Responsible for recruiting, negotiating pricing and managing blood collection centers for mobilized peripheral blood leukapheresis material.
Responsible for final product storage, inventory management and shipment of clinical material to clinical sites.
Responsible for ensuring that Manufacturing SOPs and procedures are established.
Prepares CMC section of IND filings.

Desired Skills and Experience
BS, M.S or Ph.D. in engineering or science with 10+ years of experience with manufacturing biological products under cGMP guidelines.
5+ years of experience with managing manufacturing facilities and Contract Manufacturing Facilities.
Demonstrated track record of leading and mentoring manufacturing group.
Strong knowledge and understanding of manufacturing operations, quality control, process design, and US FDA and EU cGMP regulations.
Experience with Monoclonal Antibodies, cellular therapy, blood processing or blood banking strongly desirable. Familiarity with FACT, CLIA, or AABB a plus.
Excellent computer skills including Excel, PowerPoint and appropriate analytical and statistical applications.
Must have excellent business judgment and possess strong leadership, problem solving and communication skills. Must be able to communicate with senior management and non-financial staff.
Must be detail oriented and strongly committed to quality.
Ability to work under tight deadlines in fast moving environment.

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