Manager, CMC Operations (Waltham, MA)

Position summary:

The Manager, CMC Operations will work on site in Waltham, MA to help coordinate team members. The Manager, CMC Operations will manage complex program projects, including but not limited to: external drug substance and critical intermediate manufacturing, CMC regulatory filings, overall development program material forecasting, as well as strategic initiatives.

Description:

• Act as the CMC Operations Lead to manage complex program projects including but not limited to external drug substance and critical intermediate manufacturing, CMC regulatory filings, overall development program material forecasting, as well as strategic initiatives.
• Act as primary contact for CMO business collaborations, ensuring the overall relationship between company and CMOs is healthy.
• Proactively direct the resolution of issues.
• Align internal and external functions to ensure clarity on needs, timelines, and milestones.
• Support development and management of contracts including MSAs, SOWs, Change Orders, POs, etc.
• Lead cross-functional teams comprised of internal and external subject matter experts to meet business, operations, and quality objectives and ensure successful supply availability from CMOs.
• Proactively identify risks (business, technical, quality, etc.) with internal and external teams. Create and ensure execution of mitigation plans.
• Identify metrics and drive performance improvements.
• Communicate key issues, production status, and highlights of activities.
• Help create annual CMO budget and monitor performance against plan.
• Fosters high performance teamwork, establishes strong working relationships with key stakeholders, and demonstrate personal ownership and accountability for results with a focus on customer service.
• May serve as Project Leader for critical internal projects.
• Contributes to the best practices of CMC operations to support the continued success and evolution of the broader CMC organization.

Additional Skills & Qualifications:

• BS/MS in Life Sciences preferred, with at least 5 years of technical operations experience within the biopharmaceutical or pharmaceutical industry.
• Experience with early phase drug development as well as program/project management preferred.
• Experience managing external CMOs/CDMOs.
• Understanding of CMC development, regulatory CMC requirements, and cGMP compliance.
• Must be detail oriented and organized but also able to be an active member of the project team and think strategically.
• Experience in managing complex projects / technical teams internally and/or externally.
• Ability to work with CMC team members to foster a positive team culture of ownership and accountability.
• Demonstrated history of aligning best practices across workstreams by developing standard reporting tools, metrics, agendas, minutes, and meeting structures.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.