- Lead a team of scientists responsible for development of chemical synthesis processes to support Biogen's clinical and commercial oligonucleotide programs (about 8 personnel)
- Assist in the transfer of ASO synthesis manufacturing processes internally and externally with Biogen's CMOs, arranging for on-site technical support as needed. Ensure safe and timely deliveries of preclinical supplies.
- Direct technical innovation projects with internal/external collaborators to drive innovative chemical processes for ASO manufacture. Act as the local expert for due diligence and technology assessment projects. Coordinate publication of papers and patents and build external influence within the industrial and regulatory community.
- Assist CMC teams to support global regulatory filings and partner with manufacturing teams to communicate control strategies and validation practices
- PhD in organic chemistry, chemical engineering or related field and at least 8 years of experience. Equivalent experience equals a Master's plus 10 years of experience.
- Ability to provide direction and guidance to a small team of chemists/engineers
- Expertise in organic chemistry and oligonucleotide synthesis, with a demonstrated track record of innovation.
- Understanding of manufacturing processes and technical transfer from development to manufacturing.
- Understanding of analytical methods used in the control and characterization of chemical processes for pharmaceutical manufacturing.
- Excellent written and verbal communication skills, track record of presentations and/or publications and patents.
- Good organizational skills and ability to plan and administer a project to ensure timely completion (timelines, milestone tracking)
- Highly skilled in Word, Excel, PowerPoint, and other tools. Knowledge of statistical software applications, including DoE, is a plus
- Direct knowledge and experience with synthetic oligonucleotides or siRNAs is essential. Experience authoring regulatory CMC filings is a plus.
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Associate Director, ASO Process Chemistry Lead - Cambridge, United States - Biogen Idec
Description
Job Description
Biogen is presently looking to fill an Associate Director position within its Anti-Sense Oligonucleotide (ASO) Development Group. The candidate will lead a small team responsible for the development and optimization of chemical routes to manufacture oligonucleotides to supporting Biogen's growing pipeline. The Candidate must be motivated and innovative with exceptional analytical and communication skills.
This is a hybrid role to be based at our Headquarters in Cambridge, MA.
What You'll Do
You have an in-depth knowledge of oligonucleotide synthesis development and manufacturing, a track record of innovation, a passion for leadership, and the ability to influence widely within an organization. You will lead a dynamic oligonucleotide process chemistry group 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.
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.
