Senior Manager of Biologics Manufacturing
vor 2 Monaten
Thermo Fisher Scientific is seeking an experienced professional to lead our Downstream Processes in manufacturing suites. As the Manager, DSP Manufacturing, you will be responsible for scheduling and shift rotations, as well as developing and leading a robust Manufacturing Team.
Your Key Responsibilities:- Lead daily operations of Downstream processes in manufacturing suites, including scheduling and shift rotations.
- Develop and lead a robust Manufacturing Team, ensuring efficient operations and appropriate succession planning.
- Participate in defining robust process parameters during routine manufacturing campaigns.
- Build and collaborate with cross-functional teams, including Quality Assurance, Quality Control, Manufacturing Science and Technology, Engineering, Validation, and other relevant functional areas.
- Collaborate closely with the PMO, Engineering, Quality, and Business Technology to craft, procure, and commission production equipment and automation systems in accordance with process requirements.
- Participate in Technology Transfer and operational readiness activities to implement new production processes and lines.
- Support CVQ, PQ, and Process Validation execution.
- Ensure implementation and adherence to current GMP rules, Quality policies, procedures, and instructions.
- Supply to continuous quality improvement initiatives and handle deviation reporting and follow-up.
- Bachelor/Master in Chemistry, Biochemistry, Biology, or Food Science.
- Proficient in English; proficiency in German is required.
- Over 10 years of successful experience in pharmaceutical operations within a GMP relevant environment.
- Experience in biotech or pharma processes, including sterile processes, USP, DSP, solution preparation, single-use, and CIP/SIP processes.
- Solid understanding and competence in automated processes.
- Validated experience in leading teams.
- Willingness to work occasional weekends as needed for production planning.
- Availability for on-call support.
We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Join a forward-thinking organization that values integrity, intensity, involvement, and innovation.
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