Job Description

Job Title: Scientist II, Protein Manufacturing

When you are part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you will be supported in achieving your career goals.

Location/Division Specific Information

Thermo Fisher Scientific – NDX (Legacy Microgenics) 46500 Kato Road, Fremont, CA

Part of Clinical Diagnostics Division of Specialty Diagnostics Group

How will you make an impact?

The Scientist II, Protein Manufacturing is responsible for manufacturing of products and completes associated documentation adhered to standard operating procedures (SOP) and current good manufacturing practices (cGMP). Works with chemicals and biologicals to manufacture or qualify material for IVD use. Participates in process improvement projects.

What will you do?

• Manufactures conjugated micro concentrates, protein conjugates, and buffers following cGMPs.
• Purifies protein conjugates on diafiltration system.
• Performs buffer filtrations.
• Performs analytical, functional, and diagnostic analyzer testing of conjugates.
• Weighs, transfers, and mixes required chemicals.
• Reviews in-process and completed batch records.
• Initiates and/or participates process improvement projects such as updating processes and/or equipment to improve efficiencies and supports business needs.
• Trains other chemists on equipment and procedures.
• Completes variance and non-conformance investigations.
• Updates documents via MasterControl DCO and Change Control.
• Initiates, evaluates, and supports investigations for non-conformances, CAPAs and variances.
• Performs ERP QAD transactions for work orders and inventory.
• Leads 6S and participate in Kaizen and other process improvement efforts
• Participates in weekly lab clean-ups and expired material segregations, and monthly cold box clean-ups.
• Maintains and orders lab supplies as needed.
• Writes, reviews, or modifies SOPs, work instructions and reports with guidance.
• Maintains and analyzes lot histories for trends and discrepancies.
• Maintains, troubleshoots, and validates equipment as appropriate.
• Keeps department manager updated on all issues.
• Performs other job duties as required.

How will you get here?

• BA or BS degree in Biology, Molecular Biology, Biochemistry or equivalent required.

• A minimum of 6-24 months of laboratory experience. Experience can be derived from internships or positions held post-graduation.

• Hands on experience with diafiltration, disc centrifuge, FPLC, and spectrophotometer is desired.
• Laboratory skills and knowledge of safety precautions is a plus.
• Experience in working with potentially hazardous chemicals and human source materials is a plus.

Knowledge, Skills, Abilities

• Must have excellent math and working knowledge of the metric system (weights & volumes).
• Intermediate word processing and spreadsheet software skills with excellent oral and written communication skills. Good interpersonal skills.
• Individual must work well in a team environment and be adaptable to changes in priorities.

• Self-motivated, independent, and strong critical thinking.
• Strong lab skills and knowledge of safety precautions.
• Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics.

• Familiarity with Quality System Regulations: cGMP/GDP, ISO and IVD regulations is a plus.
• Manual dexterity. Must be able to lift 25 lbs routinely. May be required to lift up to 50 lbs occasionally.

Compensation and Benefits

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