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.
Key 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:
-Technology Transfer
-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.