Work ScheduleStandard (Mon-Fri)Environmental ConditionsCleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materialsJob DescriptionPosition Summary:Manufactures complicated products and completes associated documentation. Contributes to the transfer of new products into Manufacturing. Participates in process improvement projects.Key Responsibilities:
Manufacture advanced products and complete batch records following all cGMPs.
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 product filtrations.
Review and approve completed batch records.
Maintain and analyze lot histories for trends and discrepancies.
Analyze data to perform calculations for constituent additions and dilutions.
Train junior scientists on equipment and procedures.
May write, review, and modify SOPs, work instructions and reports.
Maintain, troubleshoot and validate equipment as appropriate.
Execute process validations as appropriate.
Participate in process improvement projects to improve efficiencies and support business needs.
Initiate, evaluate, and draft write-ups for NCARs, OOS's and Variances.
Keep the department lead or manager updated on all issues.
Perform other job duties such as small equipment cleaning and autoclaving of small parts using lab autoclave and washer as required.
Minimum Requirements/Qualifications:
BS/BA in life scientific field(biology/biochemistry)with 2-4 years of related experience and/or training preferred. AA degree with 4-6 years of related experience may be substituted.
Strong lab skills and knowledge of safety precautions.
Familiarity with Quality System Regulations and ISO 13485 regulations.
Experienced working with potentially hazardous chemicals and human source materials.
Must be able to lift 25 lbs routinely.
May be required to lift up to 50 lbs occasionally.
Knowledge, Skills & Abilities:
Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities.
Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
Must be organized and diligent to be able to prioritize own and other’s work and meet business productivity metrics.
Must exhibit strong leadership ability.
Self-sufficient, self-motivated, and focused.
This position is not approved for relocation assistance.Compensation and BenefitsThe salary range estimated for this position based in California is $91,000.00–$121,000.00.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-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.
