CMC Asset Lead, Associate Director

Biogen; Cambridge (MA); Hybrid; USD 163,000 - 225,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Paid Time Off 15 days + shutdown

Job summary

Biogen in Cambridge, MA is seeking an Associate Director-level CMC Asset Lead to drive end-to-end asset leadership for clinical immunology programs within the PO&T division.

You will lead a cross-functional PO&T Asset Team, develop a 5-year asset strategy and an 18-month tactical plan, and partner with Research, Development, regulatory, and external partners to advance programs.

Qualifications

• Advanced degree (PhD preferred) in a biopharmaceutical discipline, and 8 years of relevant experience including line and matrix management.
• Experience in matrix leadership across cross-functional teams.
• CMC experience from research through IND to NDA/BLA in one or more development areas.
• Strong understanding of cross-functional interdependencies (Research, Development, regulatory, finance).
• Excellent strategic, organizational, and relationship development skills.
• Demonstrated ability to lead, influence, and manage priorities in a matrix environment.
• Demonstrated communication, negotiation, problem solving and decision-making abilities.

Responsibilities

• Serve as the PO&T asset owner for clinical programs, delivering a 5-year asset strategy and an 18-month rolling Tactical Plan.
• Lead the cross-functional PO&T Asset Team across development, manufacturing, quality, supply chain, and regulatory CMC.
• Represent PO&T on RD Program teams and coordinate between Research, Development and PO&T leadership.
• Proactively manage conflicts with Asset Strategy in consultation with governance committees and partners.
• Monitor budget, cost to commercialization, and develop business cases to secure endorsements.

Skills

Cross-functional leadership

Matrix leadership

Strategic thinking

Communication skills

Negotiation

Problem solving

Education

PhD in biopharmaceutical discipline

Job description

About This Role

The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset Lead is a member of the Asset Development & Portfolio Management (ADPM) team which provides cross-functional leadership of development programs (assets). The PO&T Asset Lead is accountable for end-to-end asset leadership including asset strategy, development, supply and life cycle management planning for all CMC aspects of clinical programs in biologics, pharmaceuticals or other modalities. This PO&T Asset Lead role is specifically responsible for leading CMC of one or more clinical immunology programs. Programs may require alliance management of corporate partners.

About This Role

The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset Lead is a member of the Asset Development & Portfolio Management (ADPM) team which provides cross-functional leadership of development programs (assets). The PO&T Asset Lead is accountable for end-to-end asset leadership including asset strategy, development, supply and life cycle management planning for all CMC aspects of clinical programs in biologics, pharmaceuticals or other modalities. This PO&T Asset Lead role is specifically responsible for leading CMC of one or more clinical immunology programs. Programs may require alliance management of corporate partners.

This is a hybrid role based in Cambridge, MA.

What You’ll Do

• Serve as the PO&T “asset owner” of clinical programs, with accountability for delivering a 5-year PO&T Asset Strategy, maintenance of an 18-month rolling Tactical Plan, monitoring key program risks and development of risk mitigation plans
• 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
• Serve as PO&T’s representative on the Research and Development Program teams; acts as in influencer and liaison between Research, Development and PO&T leadership.
• 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.
• 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. Develop business cases for key asset initiatives and secure management endorsement at the PO&T Governance Committee

Who You Are

You have leadership experience in CMC drug development, supply chain or manufacturing. 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. You will be instrumental in leading and facilitating key aspects of the PO&T vision through engagement/oversight of programs transitioning into clinical development, driving best practices for resource management/forecasting, decision gates and associated knowledge management initiatives.

Qualifications

• 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 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.
• 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

The base compensation range for this role is: $163,000.00-$225,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

Benefits

• Medical, Dental, Vision, & Life insurances
• 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)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase planTuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. 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. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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 Biogen.

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.