MSAT & Tech Transfer Senior Lead - Drug Product (m/f/d)

A dynamic biopharma organization in the Munich region is looking for an experienced MSAT & Tech Transfer Senior Lead - Drug Product (m/f/d) to support the transfer, scale‑up, and lifecycle management of drug product manufacturing processes across development and commercial stages.

This role is strongly manufacturing‑ and site‑facing, with a primary focus on Technology Transfer and MSAT , rather than early‑stage CMC strategy. You will work closely with internal manufacturing sites, external partners, and cross‑functional teams to ensure robust, compliant, and scalable processes.

Responsibilities

• Lead drug product technology transfers from development into GMP manufacturing (internal sites and CDMOs).
• Act as MSAT representative supporting:
  • Process validation and ongoing process verification
  • Technical troubleshooting during manufacturing
  • Process robustness and continuous improvement initiatives
• Support both IMP and commercial products, ensuring smooth transitions across lifecycle stages.

Manufacturing & Process Support

• Provide technical oversight for sterile and/or solid dosage form manufacturing processes, depending on project needs.
• Support manufacturing campaigns through deviation management, root‑cause analysis, CAPAs, and change control.
• Collaborate closely with Manufacturing, Quality, Supply Chain, and external partners.

CMC & Cross‑Functional Interface

• Interface with CMC Development, Quality, Regulatory, and Supply Chain teams.
• Contribute to CMC documentation (e.g. validation sections, process descriptions, tech transfer reports).
• Support regulatory submissions and inspections from a technical/manufacturing perspective.

Stakeholder & Project Interaction

• Act as a key technical contact for global manufacturing sites.
• Communicate risks, timelines, and technical challenges clearly to project and governance teams.
• Support cross‑functional project teams as a technical expert, not as overall CMC project lead.

Qualifications & Experience

• Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field (PhD or MSc).
• Typically 5-10+ years of experience in:
  • MSAT
  • Manufacturing science / process support
• Strong hands‑on experience with:
  • GMP manufacturing environments
  • Process validation and lifecycle management
• Experience with commercial products and/or late‑stage development preferred.
• Good understanding of CMC and global regulatory requirements.
• Excellent communication skills in English (German not required).
• Ability to work effectively in a fast‑paced, multicultural, and matrix environment.

SThree_Germany is acting as an Employment Agency in relation to this vacancy.