Manager, Chemistry

Job Summary

The Manager, Chemistry will oversee all testing activities for raw materials and finished goods to ensure compliance with quality, regulatory, and customer requirements. The role involves interaction with Manufacturing and Quality Assurance, budget management, and participation in inspections and audits.

Salary Range: $90,816 – $126,991. Eligible for a bonus plan with a target of 10% of base salary.

Benefits include a 401(k) plan with company contributions, paid vacation, holiday and personal days, an employee assistance program, and health coverage (medical, prescription drug, dental, and vision). Additional benefits are life insurance, disability coverage, and a wellness program.

• Directs and prioritizes multiple laboratory work teams to provide timely, accurate testing of raw materials, in‑process, and finished goods, ensuring product meets FK USA and FDA regulatory requirements.
• Oversees staff administration, ensuring adequate training, development, motivation, and adherence to quality performance standards.
• Plans and coordinates training schemes to develop cross‑trained, self‑directed work teams aligned with total quality management concepts.
• Stays current with analytical chemistry requirements, methods, and pharmaceutical changes.
• Evaluates and determines corrective actions for out‑of‑specification (OOS) or out‑of‑trend (OOT) situations.
• Provides evaluation and quality control recommendations for new processes relevant to chemistry concerns or to troubleshoot existing processes.
• Assists in the development, administration, and maintenance of the operating and capital budgets for the department.
• Represents the department in cGMP inspections and other audits as required.
• Coordinates departmental staff to ensure all obligations conform to cGMP and FK USA policies and procedures.
• Provides assistance to the organization within areas of expertise as needed.
• Facilitates a work environment that promotes development, method improvement, and achievement of personal, departmental, and company goals.
• Participates in the review of annual product review documents related to the department.
• Attends and represents the department at applicable management review meetings.
• Works with peers to develop and harmonize processes and procedures, improving compliance, capability, and capacity.
• Ensures personnel awareness of Environmental Management and Energy Management Systems, promoting continual improvement per ISO 14001 and ISO 50001 standards.
• Ensures Health, Safety, and Environmental requirements meet ISO 14001;
  Energy Management requirements meet ISO 50001; and Occupational Health and Safety compliance meets ISO 45001.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.