MSAT Recombinant DS Cluster Head

Role Summary

MSAT Recombinant DS Cluster Head located in Framingham, MA. Leads the MSAT product cluster, overseeing end-to-end technical lifecycle management, providing strategic technical guidance, and ensuring alignment with Manufacturing & Supply objectives.

Responsibilities

• Manages Technical Product Leads for their product cluster.
• Accountable for the MSAT E2E Technical Product Teams (TPT) for their product cluster.
• Acts as MSAT Lead within Industrial/Portfolio Product teams with primary responsibility to ensure a clear end-to-end technical agenda in the Industrial Product Plan.
• Be the MSAT technical voice for new pipeline products from CMC development/R&D until an MSAT CMC lead is appointed.
• Decision maker for end-to-end technical strategic product roadmap/industrial footprint within MSAT perimeter.
• Advocates for resource needs and program prioritization to MSAT LT through the Portfolio Review Forum.
• Recommends portfolio prioritization, consults with functional leadership, and influences other organizations (Operations, Quality, Regulatory Affairs, CMC Dev/R&D, and internal/external Sites).
• Guides Technical Product Leads (TPLs) and other TPT members in delivering the technical end-to-end product roadmap.
• Makes final decisions in cases of conflict with input from the TPT team.
• Leads troubleshooting or escalation to mobilize resources to address product-related issues and ensure business continuity.
• Escalates significant issues to Stakeholders/MSAT LT and ensures senior leadership alignment on critical technical decisions at Governance forums.

Qualifications

• Basic Qualifications:
  • BS, MS, or Ph.D. in Biochemistry, Chemistry, Cellular and Molecular Biology, Chemical Engineering, or related scientific discipline (BS plus 15+ years, MS with 10+ years, or PhD with 5+ years of industry experience).

Experience

• Extensive experience in process development, manufacturing, or analytics.
• Experience in technical transfer of technology processes and manufacturing into regulated facilities for commercial production.
• Excellent verbal and written communication skills; ability to influence across M&S and CMOs.
• Experience leading multi-disciplinary, matrixed teams; strong problem-solving and creative thinking to meet deadlines.
• In-depth scientific/technical knowledge across process development, product development, scale-up, operations, or analytical areas (e.g., cell culture, purification, analytical characterization, process validation).
• End-to-end product understanding from cells/seed through drug substance to drug product fill operations.
• Compliance/regulatory experience with knowledge of boards of health and regulations.
• Experience with pre- and post-launch activities (technology transfer, process validation, comparability design, continuous process verification, health authority regulations, quality systems, regulatory guidance).

Soft Skills

• Strong management, communication, and interpersonal skills; ability to set, manage, and influence goals.
• Ability to evaluate new process technologies and modalities; openness to digital opportunities.
• Ability to anticipate risks and propose mitigation plans.
• Collaborator with ability to succeed in a global/matrix environment.
• Experience managing diverse/complex product portfolios across a global manufacturing network.
• Presentation skills to influence senior/stakeholder decisions.
• Ability to develop people, coach, and provide structured feedback.

Skills

• Strong problem structuring and problem-solving skills.
• Knowledge of basic financial analysis and management accounting.
• Experience in Change Management methodologies and awareness of transformation pitfalls.
• Strong written and oral communication; ability to synthesize complex information.

Education

• Not specified beyond required degrees in Qualifications.