Manager Manufacturing Biologics

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Summary

• This position leads a manufacturing area (upstream, downstream, solution preparation and support) to ensure the operational activities for the production of recombinant products
• This position supports project teams in the design, commissioning, qualification and validation of new production lines for recombinant products
• This position supports New Product Introduction for recombinant products

Technical Responsibilities

Operational duties:

• Is responsible for the daily operations of Upstream processes in manufacturing suites, including schedule, shift rotations
• Lead and develop Manufacturing Team in order to run areas robustly and efficiently, ensuring appropriate succession planning
• Participates in defining robust process parameters during routine manufacturing campaigns
• Build cross functional teams and interact with other support functions such as Quality Assurance, Quality Control, Manufacturing Science and Technology, Engineering, Validation, and other relevant functional areas

Project duties:

• Works closely with the PMO, Engineering, Quality and Business Technology to support the design, procurement and commissioning of production equipment and automation systems in accordance with process requirements and compliance.
• Participates in Technology Transfer and operational readiness activities to implement new production processes and new lines.
• Supports CVQ, PQ, Process Validation execution.

Quality

• Ensures implementation of and adherence to current GMP rules, Quality policies, procedures and instructions for their area of responsibility.
• Ensures contribution of their unit to continuous quality improvement initiatives and deviation reporting and follow-up.

EHSS

• Ensures implementation of and adherence to EHSS legal requirements, rules, policies, procedures and instructions for their area of responsibility.
• Ensures contribution of their organizational unit to EHSS initiatives and issues as well as near miss reporting and follow-up.

Leadership

• Maintains commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
• Takes personal accountability for their presence, performance, and productivity for the achievement of defined objectives.
• Thinks and acts with a customer-centric approach.
• Is intellectually curious and adopts Practical Process Improvement (continuous improvement).
• Relentlessly attracts and develops talent to deliver exceptional performance and achieve their full potential.
• Removes barriers to success and enables a work environment where colleagues can be their best self and motivated to excel.
• Enables strategic focus by setting the right objectives prioritizing work and resources across the team and organization to improve impact.

Position Qualifications

Education

• Bachelor/Master in Chemistry / Biochemistry / Biology / Food Science
• Language: English, German is a must

Experience & Competencies

• >10 years successful experience in pharmaceuticals operations in a GMP relevant environment
• the function requires experience in biotech or pharma processes, either in sterile processes, USP, DSP, solution preparation, single use, CIP/SIP processes
• Good knowledge and competence in the field of automated processes
• Experience in leading teams

Additional Requirements

• Occasional weekend work according to need of production planning
• On-call support

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.