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.
This is a hybrid role based out of our headquarters in Cambridge, MA.
What You’ll Do
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 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
Qualifications Who You Are
You have in-depth knowledge of parenteral drug product development and manufacturing, as well as non-viral delivery of complex molecules. You have a passion for leadership, and the ability to influence widely within an organization. You will lead a dynamic oligonucleotide drug product development group of scientists and engineers and work closely with the Pharma Process Development and Regulatory CMC leadership team as well as R&D, Manufacturing and Quality teams to drive best practices and make development decisions affecting Biogen’s substantial oligonucleotide portfolio.
Required Skills
Ph.D. with at least 8 years’ experience in the biotech/biopharma industry. Equivalent experience equals a M.S. with 10+ years’ experience or a B.S. with at least 12 years' experience. Other relevant expertise in Science or Engineering may be consideredAbility to provide direction, guidance and mentoring to a team of scientists/engineersDeep expertise in the formulation of oligonucleotide or other parenteral products and in drug product development/ cGMP manufactureExpertise in analytical methods used in the characterization of formulations for pharmaceutical productsDemonstrated ability to develop innovative technologies in partnership with Research and Development teamsProven record of successfully transferring DP processes to CMOsExcellent written and verbal communication skills, track record of presentations and publications.Strong organizational skills and ability to plan and administer a project to ensure timely completion (budgets, timelines, milestone tracking)Highly skilled in Word, Excel, PowerPoint, and other tools. Preferred Skills
Knowledge of statistical software applications, including DoE, is a plusDirect knowledge and experience with oligonucleotides, siRNAs, and nanoparticle formulations is a plus
Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.