Director, CMC Asset Lead

About This Role

The Pharmaceutical Operations and Technology (PO&T) Division is seeking to fill the position of CMC Asset Lead. This role is a key member of the Asset Development & Portfolio Management (ADPM) team which is responsible for providing cross-functional leadership for development programs referred to as assets. The PO&T Asset Lead is entrusted with end-to-end leadership across all aspects of asset strategy development supply and life cycle management for the Chemistry Manufacturing and Controls (CMC) components of clinical programs in biologics pharmaceuticals or other modalities. Specifically the CMC Asset Lead will oversee one or more programs in pre-clinical to Phase 2 stages and may be required to manage corporate partners.

This position is a hybrid role based in Cambridge MA.

What Youll Do

• Serve as the PO&T asset owner for early-stage programs with full accountability for developing and delivering a five-year PO&T Asset Strategy maintaining an 18-month rolling Tactical Plan monitoring key program risks and creating risk mitigation plans.

• Lead the cross-functional PO&T Asset Team which includes representatives from process and analytical development manufacturing quality assurance supply chain device (if applicable) and regulatory CMC. Guide the team in developing and implementing both the Asset Strategy and Tactical Plan.

• Act as PO&Ts representative on Research and Development Program teams serving as an influencer and liaison between Research Development and PO&T leadership.

• Proactively elevate risks with the Asset Strategy such as those driven by other assets or line function priorities by consulting with the PO&T Governance Committee Research/Development governance or corporate partners.

• Monitor the impact of asset-related activities on the annual project budget and resources and total estimated cost to commercialization. Collaborate with PO&T Line Functions to develop tactics for cost improvement and prepare business cases for major asset initiatives securing management endorsement from the PO&T Governance Committee.

• Maintain program risk register and develop and manage mitigations to keep CMC activities off critical path.

Who You Are

You are an experienced leader with a deep background in CMC drug development supply chain or manufacturing. As a member of ADPM you will lead teams representing PO&T disciplines and cultivate essential partnerships with Research and/or Development product teams and leaders. Your leadership will be crucial in facilitating and advancing the PO&T vision by overseeing programs as they transition into clinical development. You will promote best practices in resource management and forecasting oversee decision gates and support key knowledge management initiatives.

Qualifications

• An advanced degree (PhD preferable) in a relevant biopharmaceutical discipline with at least 12 years of related experience including both line and matrix management.

• Proven record of effective matrix leadership within program teams through all stages of the product life cycle such as CMC line function sub-teams or other cross-functional teams in a matrix environment.

• Experience with CMC activities spanning research to IND and late-stage development and a solid understanding of global registration processes. Technical expertise in one or more areas of bio/pharmaceutical development is required.

• Background in the healthcare biotech or pharmaceutical industry with demonstrated understanding of cross-functional interdependencies among Research Development commercial regulatory and finance functions.

• Strong strategic organizational and relationship-building skills.

• Ability to lead motivate and influence strategic direction without direct authority leveraging and developing diverse perspectives and ideas from matrix teams and other stakeholders.

• Excellent communication negotiation problem-solving and decision-making skills.

• Demonstrated ability to identify critical program risks and implement strategic or tactical mitigation plans to reduce risk cost and reputational impact to Biogen.

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.

In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:

• 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 $10000 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 onto 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.