CMC Asset Lead, Associate Director

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

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

15 days paid vacation + year-end

Up to 12 company paid holidays + 3个人al

Tuition reimbursement up to $10,000

401(k) with company match

Employee stock purchase plan

Job summary

Biogen, Inc. seeks an experienced CMC Asset Lead at Associate Director level to guide end-to-end asset leadership for clinical programs.

You will chair a cross-functional PO&T team spanning process development, manufacturing, quality, supply chain and regulatory CMC, driving strategic planning and risk management in a collaborative biopharma setting. The role emphasizes alliance management with partners, leadership within ADPM, and influence across Research, Development and PO&T leadership as

Qualifications

• Advanced degree (PhD preferred) with 8 years of relevant experience, including line and matrix management.
• MS, MBA and/or Bachelor's degree may be considered with extensive experience.
• Matrix leadership across cross-functional program teams in a biopharma context.
• Experience with CMC in research to NDA/BLA and technical bio/pharma development.
• Experience in healthcare/biotech/pharmaceutical industry with cross-functional interdependencies.
• Excellent strategic, organizational, and relationship development skills.
• Demonstrated ability to lead, influence and drive strategic direction in matrix settings.

Responsibilities

• Lead the cross-functional PO&T Asset Team across process development, manufacturing, quality, supply chain, device, and regulatory CMC.
• Develop and deliver a 5-year PO&T Asset Strategy and an 18-month rolling Tactical Plan.
• Serve as the asset owner on clinical programs and coordinate with Research and Development leadership.
• Identify and mitigate asset risks; manage conflicts with other assets and line functions.
• Develop business cases for asset initiatives and seek endorsement from the Governance Committee.
• Monitor budget impacts and collaborate to improve cost to commercialization.

Skills

CMC drug development

Cross-functional leadership

Matrix leadership

Risk management

Communication

Negotiation

Problem solving

Forecasting

Education

PhD

MS

MBA

Bachelor's degree

Job description

About This Role

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 extensive 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.

• 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 plan
• Tuition 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.