Associate Director/ ASO Formulation and Drug Product Development Lead at Biogen in Cambridge, MA

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Job Description

Biogen is presently looking to fill an Associate Director position within its Anti-Sense Oligonucleotide (ASO) Development and Manufacturing Group. The candidate will lead a team responsible for the development of parenteral oligonucleotide formulations and drug product manufacturing (DP) processes supporting Biogen's growing pipeline. The Candidate must be motivated and innovative with exceptional analytical and communication skills.

Essential Responsibilities:

1) Lead a team of scientists/engineers to develop DS formulations and DP processes to support Biogen's clinical and commercial oligonucleotide programs
2) Lead cross-functional teams to transfer parenteral DP processes to internally and externally with Biogen's CMOs, including providing on-site technical support
3) Provide leadership support/guidance to CMC teams and subject matter expertise for global regulatory filings
4) Direct technical innovation projects with internal/external collaborators to drive innovative nanoparticle formulations, blood-brain barrier initiatives (device and formulations) drug delivery or DP solutions

Qualifications

1) Ability to provide direction, guidance and mentoring to a team of scientists/engineers
2) Deep expertise in the formulation of oligonucleotide or other parenteral products and in drug product development/ cGMP manufacture
3) Expertise in analytical methods used in the characterization of formulations for pharmaceutical products
4) Demonstrated ability to develop innovative technologies in partnership with Research and Development teams
5) Proven record of successfully transferring DP processes to CMOs
6) Excellent written and verbal communication skills, track record of presentations and publications.
7) Strong organizational skills and ability to plan and administer a project to ensure timely completion (budgets, timelines, milestone tracking)
8) Highly skilled in Word, Excel, PowerPoint, and other tools. Knowledge of statistical software applications, including DoE, is a plus
9) Direct knowledge and experience with oligonucleotides or siRNAs is a plus

Bioengineering, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related discipline:

* Ph.D. with 9+ years' experience, or M.S. with 12+ years' experience in the Biotech / Biopharm industry

* Other relevant expertise in Science or Engineering will be considered.

Additional Information

Biogen is presently looking to fill an Associate Director position within its Anti-Sense Oligonucleotide (ASO) Development and Manufacturing Group. The candidate will lead a team responsible for the development of parenteral oligonucleotide formulations and drug product manufacturing (DP) processes supporting Biogen's growing pipeline.

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