Work ScheduleStandard (Mon-Fri)Environmental ConditionsSome degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionThermo Fisher Scientific Inc. is the world leader in serving science and is currently seeking a Scientist III, Formulation to join the team in Fremont. As a Manufacturing role, this position offers a unique opportunity to contribute to the production of advanced products within a world-class organization.Responsibilities:
Manufacture advanced products and complete associated documentation.
Ensure compliance with Quality Systems documentation within a cGMP environment.
Contribute to the transfer of new products into Manufacturing.
Products include calibrators, controls, buffers, etc.
Perform in-process assays using clinical analyzers. Review and analyze data.
Weighing, transferring, and mixing of chemicals as required.
Perform large-scale and complex (multi-housing) blood and urine-based product filtrations.
Review and approve completed batch records.
Maintain and analyze lot histories for trends and discrepancies.
Analyze data to perform complex calculations for constituent additions and dilutions.
Organize product manufacture and complete to tight timelines.
Ability to train junior chemists on the accurate use of equipment and principles of conforming to cGMP procedures and processes.
May write, review, and modify SOPs, manufacturing instructions, and reports.
Maintain, troubleshoot, and validate equipment as appropriate.
Review and execute process validations as appropriate.
Initiate, evaluate, and perform investigations for NCARs, CAPAs, and Variances following Quality Systems procedures.
Lead process improvement projects as required
Keep the department lead and manager updated on all issues.
Technical expert for products and serve as a technical resource for the team.
Perform ERP transactions for work orders and inventory.
Requirements:
A Bachelor's degree in a scientific or engineering field is preferred, or equivalent experience.
2-4 years of related experience and/or training preferred.
Familiarity with Quality System Regulations.
Strong analytical skills and the ability to problem-solve.
Prior knowledge of statistical process controls preferred.
Basic lab skills and knowledge of safety precautions.
Ability to work independently and as part of a team.
At Thermo Fisher Scientific, we are committed to being an equal-opportunity employer. We value diversity and strive to create an inclusive and collaborative work environment. We believe that a diverse workforce brings different perspectives and ideas, leading to exceptional results.Thermo Fisher Scientific also offers reasonable accommodations to job seekers with disabilities. If you require any accommodations during the application process, please contact us at 1-855-471-2255 to discuss your specific needs.Join us at Thermo Fisher Scientific, where you can contribute to groundbreaking research, solve complex challenges, and make a difference in the world. Apply today at http://jobs.thermofisher.com.Compensation and BenefitsThe hourly pay range estimated for this position based in California is $34.61–$51.92.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-rewardsThermo 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.
