Scientist II, Analytical Development
Posted on: 26 Apr 2021
US
Job Description
The individual will develop and qualify analytical methods and characterize pharmaceutical drug candidates under development. The individual will also represent analytical function on cross-functional CMC teams for development strategy of pharmaceutical drug candidate. The candidate will be responsible for defining analytical control strategy for the program during early- and late-stage development, and author analytical-related regulatory filing. The work requires cross-functional interactions and the ability to work independently and creatively to influence stakeholders across the development organization. Excellent technical skills, the ability to think outside of the box, and the ability to drive experiments from proof of concept to implementation are required. The selected individual should be able to clearly communicate their results and accomplishments to a broad audience at team meetings and in written reports. Strong self-motivation and drive to make impactful contributions in a fast-paced environment is critical. The successful candidate is expected to play leading and supporting roles in different areas as needed, and to collaborate and matrix manage resources within the team in order to maximize efficiency and impact.
Qualifications
Ph.D. in analytical chemistry, pharmaceutical sciences, or related discipline with a minimum 2-5 years of experience in the industry OR MS Degree with a minimum of 6-8 years of experience.
In-depth knowledge and hands-on experience with different types of chromatography and dissolution technologies for small molecule DS and DP analysis.
Demonstrated track record with supporting DP formulation development.
Experience with analytical representation on project teams and driving the project forward.
Knowledge in other characterization techniques such as MS, KF, Raman, IR, etc.
Applied knowledge of GMP and applicable FDA, EMA and ICH guidance documents and familiarity with the USP and other compendia are expected.
Ability to develop and qualify new analytical methods.
Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, as well ability to work independently.
Experience with IND/IMPD, NDA filing is a plus
Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
Strong verbal and written communication skills, strong interpersonal skills and the ability to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
Additional Information
Biogen is seeking a qualified candidate to fill a Scientist II position within its Analytical Development organization. This individual will be responsible for method development, characterization, and program representation to support the development of small molecule pharmaceuticals from pre-clinical development through commercialization. The successful candidate will work in a highly collaborative environment to utilize their skills in partnership with internal and external experts to solve complex analytical challenges.
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
