Manager Parenterals Production Support (New Product Introduction / Life Cycle Management)
Role details
Job location
Tech stack
Job description
In this role, you are the site subject-matter expert (SME) for low-bioburden and aseptic drug product manufacturing, with a strong focus on compounding, filling and single-use systems. You lead technical problem solving and ensure that new products, process changes and new technologies are implemented robustly and in compliance with GMP. As a key Operations representative, you proactively manage stakeholders across QA, MSAT, Engineering, Supply Chain and global functions-aligning priorities, facilitating decisions and driving execution from feasibility through routine production., · Own and shape the site technical strategy for low-bioburden/aseptic compounding and filling (incl. single-use systems) as the Operations SME.
· Lead cross-functional governance for NPI, life cycle management and technology/continuous improvement projects: align stakeholders, drive decisions, manage risks and ensure timely delivery.
· Represent Operations in process design and tech transfer activities: define manufacturing concepts, ensure fit-for-purpose and lean procedures, and secure GMP-compliant implementation.
· Lead complex investigations for deviations and complaints impacting aseptic processing (root cause analysis, impact assessment, CAPA) and coach others in structured problem solving.
· Act as an inspection-ready SME: prepare and support health authority inspections and internal audits; provide clear narratives, data and documentation.
· Build strong partnerships with key stakeholders (e.g., Production, QA, MSAT, Engineering, Supply Chain): communicate transparently, facilitate alignment and escalate effectively when needed.
· Ensure compliance with GMP, EHS and SOX requirements and drive a strong quality and safety culture.
Requirements
Must have
- Master's degree (or higher) in natural sciences or engineering.
- 6+ years of experience in the pharmaceutical industry, including at least 4 years in parenteral drug product manufacturing and/or development.
- Proven ability to manage senior stakeholders and work effectively in cross-functional, matrix organizations.
- Excellent communication skills (clear, concise, fact-based) and strong ownership in driving issues to resolution.
- Fluent in German and English (written and spoken).
Preferred
- Strong technical know-how in low-bioburden/aseptic compounding and/or aseptic filling.
- Ability to lead cross-functional teams and facilitate effective decision-making.
- Strong planning skills to integrate drug product deliverables and ensure reliable execution at manufacturing scale.
- Demonstrated influencing and facilitation skills (workshops, governance/steering meetings, alignment across functions).
- Structured, data-driven problem solver who can navigate ambiguity and translate complex technical topics into actionable decisions.
Required Skills:
Preferred Skills: Agile Manufacturing, Business Intelligence (BI), Change Management, Chemistry, Manufacturing, and Control (CMC), Consulting, Cost-Benefit Analysis (CBA), Developing Others, Gap Analysis, Good Manufacturing Practices (GMP), Industry Analysis, Manufacturing Processes, Mentorship, Operational Excellence, Organizational Knowledge, Plant Operations, Process Improvements, Process Optimization, Technical Credibility