Manager Bu Par Npi/lcm
vor 4 Wochen
Manager PAR NPI/LCM
Job Responsibilities:
- Execution and support of projects in New Product Introduction and Lifecycle Management in the Business Unit Parenterals.
- Act as a representative of operations and makes sure that process follows regulatory requirements and covers operations need in terms of handling and lean procedures.
- Execution of feasibility studies in cross-functional teams.
- Execution and support of improvement projects.
- Responsible for change controls, recipe and document changes.
- Handling of quality investigations concerning process and material deviations.
- Training of project related content on the shop floor and in leadership.
- Acts as Subject Matter Expert in project related audits
- Close collaboration with production as well as with other relevant business partners.
- Follows GMP, EHS and SOX guidelines.
**Qualifications**:
**Qualifications**:
- A minimum of a bachelor’s degree in natural science or engineering is required. Master’s degree preferred
- Preferred 5+ years of experience in various fields in Pharmaceutical industry with a minimum of 5 years in a role involved in parenteral/pharmaceutical manufacturing or development
- Preferably experience with introduction of parenteral products into manufacturing sites (biotechnologically produced and/or chemically synthesized APIs), late stage development activities as well as technical and process knowledge of manufacturing site unit operations (e.g. compounding, milling, and filling of liquid formulations and suspensions)
- Demonstration of leadership in providing oversight and guidance of manufacturing activities and sharing information within a diverse community of professionals and across multifunctional groups
- Strong planning and logistics skills to effectively integrate drug product deliverables and execution at the manufacturing level
- Knowledge of manufacturing site systems and procedures (e.g. SAP or equivalent)
- Excellent written and oral communication skills and ability to influence partners, peers and collaborators at all levels
- Proficiency in German and English is a requirement
- Ability to work independently with proven problem-solving skills
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