Manager, USP Manufacturing

at  Thermo Fisher Scientific

JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Here’s a powerful opportunity - the chance to work at an innovative multi-purpose manufacturing facility specifically crafted for large-scale biologics production with extraordinary potential for growth.
As the Manager, USP Manufacturing, you will play a vital role in leading and crafting an impactful team to ensure detailed operations in producing recombinant products. You will also provide support to project teams in the design, commissioning, qualification, and validation of new production lines, driving our mission to improve the world’s health, cleanliness, and safety.

YOUR QUALIFICATIONS:

• 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. Thermo Fisher Scientific provides employment within an innovative, forward-thinking organization, offering outstanding career and development prospects. Join us and thrive in a company culture that values integrity, intensity, involvement, and innovation

• Lead daily operations of Upstream 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.