Scientist II, Chemistry

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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.