Team Leader, Formulation Manufacturing

at  Thermo Fisher Scientific

JOB DESCRIPTION

Position Summary
Thermo Fisher Scientific West Hills manufactures medical diagnostic kits used in the Organ Transplant Diagnostics market. The environment is dynamic and fast-paced, relying on collaboration, multitasking, and communication within the team and the larger organization. The Team Leader, Manufacturing is the first formal leadership position in manufacturing. The Team Leader performs manufacturing tasks while also being responsible for manufacturing staff in those same tasks. Other related work includes supporting process improvement, authoring/ revising SOPs, auditing facility for adherence to safety and regulatory requirements.

Key Responsibilities:

• Provide hands-on manufacturing support to staff as needed per SOP.
• Lead all aspects of manufacturing staff in the manufacture of products and assure they align with regulations and current Good Manufacturing Practices (CGMPs).
• Assist supervisor in scheduling, SOP authoring/ revising, batch record review and similar supporting tasks in the manufacture of products.
• Serve as supervisor in supervisor’s absence or as delegated by supervisor.
• Develop, deliver training, and approve staff proficiency in manufacturing tasks.
• Implement process improvement through informal/formal methodologies to minimize waste and
• increase efficiency.
• Investigate and lead problem solving activities including nonconformances and CAPAs.
• Use inventory management systems (i.e. SAP) to open/ close manufacturing work orders, confirm inventory, and other such related tasks.
• Lead all aspects of team members, assess performance, and complete formal performance and coaching process.
• Continue in learning scientific concepts of products and manufacturing for area of responsibility.
• Perform other tasks as assigned within the context of confirmed skills.

Minimum Requirements:
A combination of education and experience that confer the needed manufacturing, scientific, and

laboratory technical skills. Team Leaders typically have these credentials:

• High School Diploma and 4 yrs of of lab/ scientific/ manufacturing biotech/ pharmaceutical/ medical device experience.
• Bachelor’s degree in Engineering, Biological Sciences, Chemistry or related science field and at least (preferred) two (2) years of lab/ scientific/ manufacturing biotech/ pharmaceutical/ medical device experience.
• Intermediate knowledge of GMPs within medical device/ biotech/ pharmaceutical manufacturing industry.
• Some knowledge of HLA or tissue typing technologies, molecular biology/ cell culture.
• Intermediate knowledge of Microsoft Word and Excel.
• Demonstrated leadership experience on a project or cross-functional team
• Ability to complete and author/ revise written procedures in standard English.
• Able to work with biological and chemical reagents, lift up to 35 pounds, perform detailed, focused work in various lab settings using automated equipment, pipettes, centrifuges, and cold rooms.
• Some exposure or experience in formal process improvement methodology.
• Knowledge of inventory management principles and software such as SAP or related.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action Employer

• Provide hands-on manufacturing support to staff as needed per SOP.
• Lead all aspects of manufacturing staff in the manufacture of products and assure they align with regulations and current Good Manufacturing Practices (CGMPs).
• Assist supervisor in scheduling, SOP authoring/ revising, batch record review and similar supporting tasks in the manufacture of products.
• Serve as supervisor in supervisor’s absence or as delegated by supervisor.
• Develop, deliver training, and approve staff proficiency in manufacturing tasks.
• Implement process improvement through informal/formal methodologies to minimize waste and
• increase efficiency.
• Investigate and lead problem solving activities including nonconformances and CAPAs.
• Use inventory management systems (i.e. SAP) to open/ close manufacturing work orders, confirm inventory, and other such related tasks.
• Lead all aspects of team members, assess performance, and complete formal performance and coaching process.
• Continue in learning scientific concepts of products and manufacturing for area of responsibility.
• Perform other tasks as assigned within the context of confirmed skills