Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe are examples of what we do daily!
The Transplant Diagnostics Division is a leading provider of innovative solutions and services tailored specifically for the transplant industry. For more than 35 years We have remained dedicated to improving patient outcomes, manufacturing quality products, improving processes, and improving the overall transplant experience for both healthcare professionals and patients. As we continue to grow and expand, we are seeking an experienced Director to lead and scale our technical, engineering and scaling expertise.
How will you make an impact:
Reporting to the Senior Director of Operations, the Director of Manufacturing Sciences based in West Hills, CA, will play a critical role in leading and coordinating the successful transfer of technology and processes to manufacturing within the Transplant Diagnostic Division. This position requires a strong technical background and expertise in cell and molecular biology with knowledge of Product Commercialization Process, Automation, Engineering, and project management to ensure seamless and efficient transfer of products and technologies into the manufacturing environment. The Director will lead the Manufacturing Sciences and the Engineering teams and collaborate with cross-functional teams and external partners to drive the successful execution of technical transfer projects.
What you will do:
Lead and develop teams through the technical transfer process for new or existing products
Partner regularly with Customers and internal collaborators (R&D, Commercial, Product Development, Production, and others to implement transfer strategies
Provide technical framework and plans to support NPI transfer process, scale-up for manufacturing and support assay, process, and equipment validation
Provide technical leadership for on-market products which include supporting future versions, trouble shooting, technical quality investigations, and CAPAs.
Identify and mitigate risks and obstacles that may impact the transfer process, proactively implementing solutions to ensure project success.
Monitor and report on project progress, including timelines, achievements, and prioritization, ensuring timely completion and adherence to budget.
Provide technical expertise where appropriate for technical investigation and technical reports, and process related issues during transfer.
What You bring:
Bachelor's degree in Chemistry, Biochemistry, Biology, or related science required. Masters or PhD preferred.
Shown experience in the regulated life sciences industry with direct technical experience.
8 years experience in a management role, leading multi-functional teams.
5+ years exposure and awareness of engineering and automation practices in a manufacturing environment.
Equivalent combinations of education, training, and meaningful work experience may be considered.
Knowledge of regulatory requirements and industry
Experienced independent leader to work autonomously in strategic decision making
Compensation and Benefits
The salary range estimated for this position based in California is $160,100.00–$240,125.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
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.