Mar 28, 2020

Director, ASO Formulation and Drug Product Development Lead

  • Professional Diversity Network
  • Cambridge, MA, USA
Full-Time Science

Job Description

Biogen

Job Description

Biogen is presently looking to fill a 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.

1) Lead a team of scientists/engineers to develop DS formulations and DP processes to support Biogen's clinical and commercial oligonucleotide programs (6-10 personnel)

2) Lead cross-functional teams to transfer parenteral DP manufacturing processes internally and externally with Biogen's CMOs, including providing on-site technical support, troubleshooting, and intercompany communication

3) 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- acts as the local expert for due diligence and technology assessment projects

4) Provide leadership support/guidance to CMC teams and subject matter expertise for global regulatory filings- devise filing content strategy for global dossiers and partner with manufacturing teams to communicate control strategies and validation practices

#LI-ML1

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, siRNAs, and nanoparticle formulations is a plus


Education

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

  • Ph.D. with 10+ years' experience, or M.S. with 15+ 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 a 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.

States

MA  

Apply Now