Biogen
CMC Asset Lead, Associate Director
Cambridge, MA, USA · Director
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About the role
- This is a hybrid role based in Cambridge, MA.
Responsibilities
- Lead the cross-functional PO&T Asset Team including representatives from process/analytical development, manufacturing, quality, supply chain, device (if applicable) and regulatory CMC, in the development of and delivery on the PO&T Asset Strategy & Tactical Plan
- Proactively manage conflicts with the Asset Strategy (e.g., driven by other Assets and/or Line Function priorities) in consultation with the PO&T Governance Committee, Research/Development governance, or corporate partners.
- Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others.
- Develop business cases for key asset initiatives and secure management endorsement at the PO&T Governance Committee
- You will be part of ADPM and lead teams representing PO&T disciplines and maintaining critical partnerships with relevant program Research and/or Development product teams and leaders.
Requirements
- You have leadership experience in CMC drug development, supply chain or manufacturing.
- Experience in matrix leadership experience in the setting of program teams across the full product life cycle, e.g., (CMC) PO&T line functions sub-teams or other cross-functional teams operating in a matrix environment.
- Experience with CMC in one or more areas from research to IND to NDA/BLA,.
- Technical expertise in one or more relevant bio/pharmaceutical development discipline.
- Advanced degree (PhD preferred) in a relevant biopharmaceutical discipline, and 8 years of relevant experience including line and matrix management. MS, MBA and/or Bachelor's degree may be considered with commensurate experience.
- Experience with CMC in one or more areas from research to IND to NDA/BLA,. Technical expertise in one or more relevant bio/pharmaceutical development discipline.
- Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., Research, Development, commercial, regulatory, finance)
- Excellent strategic, organizational, and relationship development skills
- Demonstrated ability to lead, motivate, influence without authority a strategic direction
- ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others.
- Demonstrated communication, negotiation, problem solving and decision-making abilities
- Demonstrated ability to identify critical program risks and develop mitigation plans - strategic or tactical - to mitigate risk, costs, and reputation of Biogen.
- Job Level: Management
- Additional Information
Nice to have
- Advanced degree (PhD preferred) in a relevant biopharmaceutical discipline, and 8 years of relevant experience including line and matrix management.
- MS, MBA and/or Bachelor's degree may be considered with commensurate experience.
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
- Monitor asset-related impacts on the annual project budget and resources and cost to commercialization (e.g., expenses, COGS, excess production, OPEX) and collaborate with the PO&T Line Functions to develop tactics to improve them.
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Employee stock purchase plan
Company info
- We are a global team with a commitment to excellence, and a pioneering spirit.
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.