Location: Cambridge, MA
partner organizations and with stakeholders from R&D through to manufacturing. The technical product lead will act as an overall technical SME for the product from R2D transition through to commercialization and will be the primary contact for product related questions.
In addition, the PTL will be accountable to drive the technical product strategy as well as year over year performance in terms of productivity and reliable manufacturing performance. The PTL will lead a matrix team to drive product strategy and coordinate all technical deliverables in the CMC Sections of INDs, NDA/MAA submissions. The PTL will also monitor product performance and be accountable to provide updates and
influence decision making by PO&T leadership via appropriate forums. This is a hybrid role that can be based in Research Triangle Park, NC or Cambridge, MA. Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.
What You'll Do Technical representative and Technical Team lead at Asset teams. Responsible to lead cross functional matrixed technical team to set, drive and deliver technical Asset goals within established timelines ASO portfolio development coordination. Ensure development deliverables - including tox batches, development and process characterization studies etc. - are planned, tracked and completed in a timely manner.
Coordinate technical Sections for IND and NDA/MAA submissions within set timelines and point of contact to coordinate responses to Information Requests from regulatory authorities.
Drive technical aspects of the integrated control strategy for ASO programs, including collaboration with Preclinical Safety and Quality to establish appropriate specifications for release and stability End to end product oversight from early development (pre-R2D) through to commercial manufacturing to ensure consistent performance and to ensure product performance oversight to drive early detection of issues before they impact quality performance or supply. Also includes coordination between Manufacturing, Quality and CMC teams to ensure smooth product transitions from development to commercial production.
Propose asset technology strategies through backssment of academic and industry trends to identify new technologies or approaches to drive product performance and reliability Drive LCM and other Yo Y improvements to drive productivity, improved COGM and manufacturing reliability. Qualifications Who You Are As the CMC Lead for antisense oligonucleotides (ASOs), you are a highly skilled and motivated professional with a deep understanding of oligonucleotide (or related compound) development and manufacturing processes.
You possess extensive experience in leading cross-functional teams to drive all Chemistry, Manufacturing, and Controls aspects of oligonucleotide drug development and commercialization. Your expertise lies in generating strategies and executing plans to ensure the successful transition of ASOs from research through to commercialization. Required Skills Bachelor's degree with at least 12 years' experience in Biopharma technical/process development. Equivalent experience equals a Master's degree and at least 10 years of experience Proven experience in leading Matrix teams Demonstrated expertise and experience in process development and commercialization of ASOs (or related products)Extensive knowledge of regulatory requirements for ASO (or similar) products Strong analytical and problem solving skillinteractioncellent communication and presentation skillinteractionperience in the preparation of Module 3 sections and prior engagement with regulatory authorities Preferred Skills Ph DAdditional 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 interaction, gender identity or expression, interactionual 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. PDN-9a733ba1-b361-49fa-a87d-8482f753eb7d For more details: jobs-search. org/manufacturing_cambridge-c434666/product-technical-lead-antisense-oligonucleotides-cambridge_i1959025791
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