Sterile Manufacturing Senior Manager
vor 1 Tag
I am working with a Contract Development & Manufacturing Organization (CDMO), specializing in manufacturing of biopharmaceutical products for customers across Europe, North America, and APAC. The company is currently expanding its sterile production capabilities.
To strengthen the leadership team, we are looking for a Senior Manager, Sterile Manufacturing, who will take full responsibility for the site's sterile production operations.
Key Responsibilities
- Lead and develop a team of 30+ employees within aseptic manufacturing, including shift leadership, training, and performance management.
- Ensure full compliance with GMP and EU Annex 1 requirements for sterile filling and formulation (SVP/LVP).
- Oversee daily production scheduling, capacity management, and allocation of critical resources.
- Collaborate closely with Quality Assurance, Engineering, MSAT, Supply Chain, and Client Project Management.
- Lead and support regulatory and customer audits (FDA, EMA, client audits) and oversee CAPA, deviation, and change control processes.
- Drive a culture of Right-First-Time execution, safety, and continuous improvement (Lean, Six Sigma).
- Support the implementation and qualification of new filling lines, validation activities, and technical optimization projects.
- Manage the department budget, workforce planning, and investment requests.
- Represent the Sterile Manufacturing department in client meetings and site-wide strategic initiatives.
Candidate Profile
- Degree in Pharmacy, Biotechnology, Chemical Engineering, Food Technology, or a comparable scientific discipline.
- 7–10+ years of experience in sterile manufacturing (aseptic processing, fill & finish, formulation).
- Strong knowledge of GMP, regulatory expectations, and EU Annex 1 requirements.
- Demonstrated experience leading larger teams in a regulated manufacturing environment.
- Excellent communication, problem-solving, and organizational skills.
- Fluency in German and English (written and spoken) is required.
If this position seems of interest, please send your CV to
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