Scientist II, Chemistry

Work Schedule

Environmental 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:

• Bachelors 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

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: Experience:

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