Manager, Formulation Manufacturing

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

US - Fremont, CA

NDX, SDG

How will you make an impact?

The Manager, Formulation Manufacturing is responsible for managing the activities and outcomes of the Molecular Controls business including management of the day-to-day activities of the laboratory staff. The position requires creativity, adaptability, and innovation in an exciting and fast-paced, team-oriented and multidisciplinary environment.

What will you do?

People Leadership

• Selects, develops, and evaluates personnel for talent management, including leadership growth and key skill-set development for operational and strategic objectives.
• Inspires, influences, and empowers employees across the matrix (both direct and indirect teams) to over-achieve objectives.
• Works effectively with cross-functional teams such as Sales, Marketing, Finance, Support, Purchasing, and Research and Development. Ensures these teams are aligned around resources and support necessary to meet and/or exceed customer needs.
• Leads the day-to-day operations of the Molecular Controls staff.

Quality Oriented

• Manufacture complex products following cGMP and completes all necessary documentation in accordance with quality system.
• Provides guidance and training to employees to ensure QSR and ISO13485 requirements have been properly implemented and are continually practiced.
• Manage department non-conformances and Corrective Action Preventive Action (CAPAs) and actions to closure.

Operational Excellence

• Provide oversight to Manufacturing personnel to meet department key performance indicators (KPIs).
• Manage the department to meet on-time delivery, quality, safety and productivity goals.
• Develops policies and procedures, and explores new capabilities through use of Practical Process Improvement.
• Strong ability to deliver projects in a high pressure environment with flexible scheduling and execution. Provides on time results to a customer base that has highly-customized deliverables.
• Knows the most effective and efficient way to get things done with a focus on continued improvement.
• Technical lead for the molecular controls (QC products) manufacturing group.

Minimum requirements/qualifications

• B.S. degree in Molecular Biology, Biochemistry or related field AND 5 years industry experience in IVD medical device field; OR master’s degree in Molecular Biology, Biochemistry, or related field AND 3 years industry experience in IVD medical device field
• Hands-on experience with qPCR, ddPCR, NGS and cell culture
• Direct working experience with bulk manufacturing process
• Familiarity with Design Control process
• Familiarity with Quality System Regulations and ISO 13485 regulations
• Strong laboratory skills including pipetting, safety, and hazardous chemical handling
• Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics
• Experience in implementing or working with an effective continuous improvement i.e. LEAN, Six Sigma, etc.
• Practical understanding and experience with IT systems (ERP, MES, WMS etc.)
• Self-motivated, independent, and a proactive driving force of execution