Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditions
Job Description
Position Summary:
The Scientist II, Chemistry will be responsible for developing and maintaining process control systems to ensure consistent product quality, with a focus on supporting the insourcing of materials and components. This role leads cross-functional efforts to qualify internal processes, validate materials, and transition manufacturing activities from external suppliers. The engineer ensures compliance with GMP, GDP, and regulatory standards while driving process improvements, supporting investigations, and managing documentation throughout the insourcing lifecycle.
Key Responsibilities:
- Develop and maintain robust process control systems to ensure consistent product quality and operational efficiency, particularly for insourced materials.
- Analyze manufacturing and supply chain processes to identify bottlenecks, deviations, and continuous improvement opportunities.
- Partner cross-functionally (Quality, Product Development, Manufacturing, Supply Chain) to qualify materials, processes, and suppliers for insourcing initiatives.
- Lead and execute material and process insourcing efforts, transitioning from external suppliers to internal operations.
- Drive root cause analysis and implement corrective/preventive actions during quality investigations tied to new materials or processes.
- Author and manage technical documentation (batch records, specifications, validation protocols) to support qualification and validation activities.
- Define inspection criteria, material acceptance standards, and validation approaches in collaboration with engineering and quality teams.
- Manage project execution, including timelines, documentation workflows, and milestone tracking to ensure on-time delivery of insourcing initiatives.
- Serve as a cross-functional liaison to enable seamless integration of insourced materials across manufacturing, quality, supply chain, and IT.
- Ensure compliance with SOPs, GMP/GDP standards, and regulatory requirements while training teams on new processes and materials.
- Evaluate product specifications and support test method harmonization initiatives across sites to drive standardization, consistency, and global scalability.
- Apply hands-on experience with analytical development instrumentation (HPLC, GC-MS, LC-MS) to support method development, validation, troubleshooting, and material qualification.
Qualifications:
- Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related technical field.
- 4+ years of experience in an analytical development, process engineering, or manufacturing environment, preferably in a regulated industry.
- Experience with validation, process transfer, or insourcing/technology transfer is highly preferred.
- Strong understanding of GMP, GDP, and regulations.
- Demonstrated ability to lead cross-functional projects and manage multiple priorities.
- Excellent written and verbal communication skills.
- Proficiency in technical writing and documentation control systems.
Compensation and Benefits
The salary range estimated for this position based in New Jersey is $79,200.00–$118,800.00.
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-rewards
