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Scientist I, Formulations
3 months ago
How you will make an impact
The formulations scientist will manufacture products for the bulk formulations team and complete associated cGMP documentation. You will work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvements projects.
What you will do
Manufacture products including reagents, calibrators, buffers, controls, and intermediates, and complete batch records while maintaining cGMPs and GDP standards
Perform in-process testing using clinical analyzers, review and analyze data
Review other manufacturing operators/scientist’s batch records
Maintain and analyzes lot histories for trends and discrepancies
Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration
Participate in process improvement projects to improve efficiencies and support business needs
May modify SOPs, work instructions and reports with guidance
Initiate and support investigations for nonconformances and deviations
Maintain and troubleshoot equipment as appropriate
Keep department supervisor and/or manager updated on all issues
Perform other job duties as required
How you will get here
Education
High shool diploma or equivalent required
BS/BA in scientific field (Chemistry or Biochemistry preferred)
Equivalent combination of education and years of related experience may be substituted
Experience
1+ years of related experience and/or training preferred
IVD immunoassay manufacturing experience is preferred
Experience in working with potentially hazardous chemicals and human source materials preferred
Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
Knowledge, Skills, Abilities
Strong laboratory skills including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions
Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
Ability to be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics
Self-sufficient, self-motivated, and focused
Physical Requirements / Work Environment
Ability to routinely lift 25 pounds
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Compensation and Benefits
The salary range estimated for this position based in California is $64,–$86,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 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) retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
