Head of Manufacturing, Gene Therapy Operations
Posted on: 1 Jul 2021
Research Triangle Park, NC
Job Description
What You’ll Do
Provide leadership to ensure a high level of communication and coordination between the production operations and the support departments to address issues and meet production schedules
Lead a multi-faceted team through start-up to licensure, covering Microbial Plasmid expression, Mammalian based production phase and Gene Therapy final fill operations
Establish and refine an operational vision that ensures the highest standards of employee safety and environmental protection, the highest standards of compliance and overall operational excellence
Ensure that the key start up milestones are being met
Develop near and long-term strategy and plans associated with new process introductions, facility utilization and manufacturing flexibility
Build organizational and operational capability to meet the needs of the business
Lead the manufacturing team position during regulatory audits
Embody the Biogen core behaviors, leadership competencies and provide thoughtful and high-quality leadership to the Gene Therapy Team
Who You Are
You are a strategic leader that influences business outcomes with high quality manufacturing decisions. You are dedicated to contributing to the generation of pioneering gene therapies.
#LI-CL1
Qualifications
Education
University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines
Required Skills
Typically requires 12-15 years' experience in pharmaceutical or biotech manufacturing environment
Prior experience with facility construction and Biotech operations
Proficiency with manufacturing and business processes associated with automation and integration of novel production systems
Strong Communication and stake-holder management skills
Prior experience with Gene Therapy operations or live virus vaccine manufacturing.
Strong GxP knowledge
Preferred Skills
Prior experience in Gene Therapy Manufacturing operations and startups is preferred
Biogen
Cambridge, MA
Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.
Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.
The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.
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IndustryBiotechnology
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No. of Employees7,800
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Website
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Jobs Posted445
