Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, 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 materials

Job Description

Position Summary

Join our ambitious and dynamic Technical Operations team at Thermo Fisher Scientific Inc. as a Scientist III, Manufacturing Sciences in West Hills, CA. This role is uniquely positioned to lead high-impact projects and collaborate with multi-functional teams to ensure flawless execution of technology transfer, process validations, and change control activities. You will be at the forefront of driving innovation and ensuring the highest standards of quality and compliance.

• Lead and complete validation projects and protocols in support of equipment, method, and process validation of moderate to high complexity.
• Lead discussions on validation strategy and statistical justification using scientific principles, compliance knowledge, and a risk-based approach that meets quality standards.
• Lead collaboration with the program management, R&D, and manufacturing teams to ensure successful process development and technology transfer.
• Lead and perform risk assessment exercises in support of validation activities and perform technical reviews as needed.
• Lead root cause analysis and suggest solutions and/or workarounds for recurring issues of high complexity.
• Complete analytical and functional testing of various antibody-based assays and molecular assays.
• Write feasibility, validation, and analytical testing protocols and reports.
• Participate in Practical Process Improvement Lean Enterprise initiatives to drive improvements in customer delivery, quality, and cost reduction/avoidance for growth and profitability.
• Train and provide support to Operations to ensure protocols are completed as intended.
• Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product, and process validation.
• Review installation qualification, operational qualification, and performance qualification protocols and reports.
• Recommend approval or failure of validation studies.
• Act as a resource to other departments for product and process knowledge.
• Act as a mentor to other Technical Operations team members.
• Provide technical expertise for Kaizen events and other Lean initiatives.
• Embrace Thermo Fisher's core 4-I values.

• Bachelor's degree in Biological Sciences, Chemistry, Molecular Biology or Engineering with 3+ years manufacturing in an IVD industry, cGMP and/or ISO regulations for diagnostics manufacturing or 2+ years demonstrated experience in technology transfer from R&D to manufacturing.
• OR Master's degree in Biological Sciences, Chemistry, Molecular Biology or Engineering with 2+ years manufacturing in an IVD industry, cGMP and/or ISO regulations for diagnostics manufacturing or 1+ years demonstrated experience in technology transfer from R&D to manufacturing.
• OR PhD in Biological Sciences, Chemistry, Molecular Biology or Engineering with 1+ years relevant industry experience .

• Previous experience running antibody-based assays or molecular assays.
• Microbiological assay development, protein purification/solid-phase immunochemistry, or PCR techniques.
• Hands-on knowledge of moderate to complex microbiological lab skills and techniques.
• Strong analytical skills, with an ability to use scientific knowledge and statistical methods/DOE to identify root causes of process and product failures.
• Able to successfully lead a project involving a group that may include participants from all levels of the business.
• Knowledge of HLA.
• Process validation and IVD design transfer proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), process validation, method validation, and computer/automation systems.
• Strong project management and organizational skills. Project Management certification (PMP) is a plus.
• Possess a continuous process improvement approach with the ability to effectively lead and manage change.
• Able to work independently, with little support from Technical Operations team.
• Ability to learn new products and technology at a fast speed.
• Some working knowledge of MiniTab/JMP skills.
• Excellent verbal and written communication skills.
• Previous experience in problem-solving methodology.
• Proficient in use of Microsoft Office Suite.
• Must be able to travel as needed.

• 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