Sr Manager, Manufacturing

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Title: Sr Manager, Manufacturing Operators

Schedule: Standard 1st Shift - Mon to Friday

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
 

Division/Site Specific Information

Our Cell Therapies San Francisco site is part of the Drug Substance Division (DSD)of the Pharma Services Group (PSG). Launched in May 2023, we operate out of a 44,000-square-foot innovative facility on the UCSF Mission Bay campus in San Francisco. Our focus lies in delivering pre-clinical development and clinical/commercial manufacturing services for gene and non-gene modified cell therapies aimed at addressing diverse unmet medical needs.

Discover Impactful Work:

This critical site based role is instrumental in leading the manufacturing operations within an innovative clean room. Responsibilities are focused on hiring, training, and developing manufacturing team members to deliver excellence in operations. The foundation of everything we do is anchored in safety and quality integrated within a continuous improvement approach.

A Day in the Life:

• Ensure the safe, high quality, and on-time manufacture of cGMP biopharmaceutical products for pre-clinical, clinical, and commercial use.

• Responsible for ensuring that all production operations (scheduling, execution, NPI) are controlled and performed within cGMP regulatory guidelines and Thermo Fisher Scientific global quality standards.

• Exceeding service levels and overall customer experience while maintaining an efficient and safe manufacturing environment is a clear result for this role.

• Participate and present during customer audits/visits. Responsibilities will include owning the manufacturing capacity, capability, and risk mitigation portion of these interactions.

• Collaborate with multiple functional areas and work streams, bringing a manufacturing mentality to deliver the best solutions for the customer.

• A key result for this leader will be to optimally hire, train, and develop team members using people centered and situational leadership in conjunction with the Thermo Fisher Scientific performance management tools to build the best team.

Keys to Success:

Education

• Bachelor's degree in scientific or engineering subject area required.

• Master’s degree in a scientific, engineering, or business subject area preferred.

Experience

• 6-8 years of validated experience in either cell therapy operations, commercial drug substance manufacturing, or commercial drug product manufacturing in an FDA regulated environment is required.

• 5 years consistent track record of leading teams.

• Experience with engaging externally facing customers within a contract development and manufacturing organization (CDMO) highly preferred.

• Commercial biologics manufacturing experience is required.

Knowledge, Skills, Abilities

• Ability to work within a matrixed cross-functional team structure.

• Ability to balance multiple projects and results simultaneously.

• Capable of leading people in multi-disciplinary technical and scientific teams.

Physical Requirements / Work Environment

• Exposure to life sciences Biosafety level 2 R&D laboratory, manufacturing space and office environment.

• Flexibility to work after hours depending on business needs.

• Up to 10% travel may be required.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.