Engineer III, OSD Manufacturing Sciences
Posted on: 30 Jan 2021
Research Triangle Park, NC
Job Description
Job Description
The Engineer III, Manufacturing Sciences will provide technical expertise to the clinical, PPQ, and commercial manufacturing campaigns run at the DP site. As appropriate, responsibilities include:
* Lead Process Transfer teams, technical improvement projects, and technical process investigations as needed.
* Provide decisions for manufacturing implementation; communicate analysis and decisions to the technology transfer team
* Provide technical and operational guidance to Manufacturing during GMP campaigns
* Lead technical investigations towards process impact assessments and ensure timely completion and communication
* Author Manufacturing and process validation protocols and technical reports.
* Improve MS business systems
Qualifications
* Biochemistry, Bioengineering, Biochemical, Chemical Engineering or related discipline: M.S. with at least 2 years experience or BA/BS with at least 4 yrs. relevant experience in the Biotech / Biopharm industry.
* Good communication and project management skills appropriate for leadership of tech transfer projects
* Strong Oral Solid Dose laboratory skills and associated analytical techniques
* Comfortable analyzing scientific datasets
* Ability to work independently and lead a large cross-functional group
Additional Information
The Engineer III, Manufacturing Sciences will provide technical expertise to the clinical, PPQ, and commercial manufacturing campaigns run at the site
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
