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Scientist/Sr. Scientist, Formulation and Drug Product Development

Posted on Apr 5, 2021 by Biogen Idec

Cambridge, MA 02138
Research
Immediate Start
Annual Salary
Full-Time


Job Description
The ASO Drug Product group is actively seeking an enthusiastic and highly motivated scientist responsible for parenteral oligonucleotide formulation development/characterizations, fill/finish process development/characterizations, technology transfer, and regulatory authoring for quickly expanding ASO pipelines and life cycle management projects in Biogen. The responsibilities include;


Acting as the technical representative in a cross functional team to support ASO drug product formulation development/characterizations, fill/finish process development/characterizations and technology transfer


Authoring and reviewing guideline documents, technical protocols, reports, process control strategy, risk assessments, and CMC regulatory filings for IND and marketing applications


Driving continuous improvement in ASO formulation development process through technological advancements/innovations


Delivering progress reports and presentations to promote management awareness and engagement of the status, progress, and future program and functional needs


Working effectively in a highly matrixed team environment to advance programs inspire change, improve efficiency, and foster positive relationships


Additional Responsibilities for Sr. Scientist Level:


Demonstrated leadership to work with multi-functional teams and dynamic environment on a fast pace to achieve timely deliverables


Team leader overseeing and participating in the planning, design, implementation and documentation of formulation development and fill/finish process development studies to support Biogen's ASO drug product platform development strategy


Supervise one or two direct reports


Qualifications
Hands-on experience in ASO or protein parenteral formulation, fill/finish process development, process characterization, technical transfers to manufacturing sites or CMOs, and DoE studies and regulatory authoring
Good knowledge of formulation, aseptic processing, sterility assurance, statistic modeling and regulatory filings is preferred
Experience in drug product regulatory strategies and agency engagement is a plus
Knowledge of, and hands-on experience with nanoparticle and or medical device delivery systems is a plus
Knowledge of and experience in oligonucleotide manufacturing is a plus
Strong problem solving, effective multi-functional communication skills and excellent organization skills
Education:


Scientist II: B.S.(+8-10 years), M.S.(+6-8 years), or PhD (+2-5 years) in Biotechnology, Material Science, Engineering, Chemistry or related subject area


Sr. Scientist: B.S.( years), M.S.(+8 years), or PhD (+5 years) in Biotechnology, Material Science, Engineering, Chemistry or related subject area




Reference: 1152695650

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