What are the responsibilities and job description for the Manager, Analytical Development position at Fresenius Kabi USA?
Job Summary
Lead the site’s Analytical Development function responsible for the design, validation, transfer, and lifecycle governance of analytical methods supporting commercial and pipeline products. Manage a team of analytical scientists, setting priorities, removing roadblocks, and ensuring right first time transfers into Quality Control. Own laboratory readiness (instrument qualification/validation, CSV, ALCOA/data integrity) and resource stewardship (OPEX/CAPEX planning). Partner cross functionally with Quality Control, Quality Assurance, Regulatory Affairs, New Business Development, and external vendors/contract labs to accelerate product introductions, resolve complex method issues, and sustain compliance with pharmacopeial and corporate standards. Report to the QC Director and deliver measurable outcomes in transfer cycle time, method robustness, data integrity, and audit readiness.
Salary Range: $90,816-$130,000/year 10% annual bonus
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Responsibilities
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
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.
Lead the site’s Analytical Development function responsible for the design, validation, transfer, and lifecycle governance of analytical methods supporting commercial and pipeline products. Manage a team of analytical scientists, setting priorities, removing roadblocks, and ensuring right first time transfers into Quality Control. Own laboratory readiness (instrument qualification/validation, CSV, ALCOA/data integrity) and resource stewardship (OPEX/CAPEX planning). Partner cross functionally with Quality Control, Quality Assurance, Regulatory Affairs, New Business Development, and external vendors/contract labs to accelerate product introductions, resolve complex method issues, and sustain compliance with pharmacopeial and corporate standards. Report to the QC Director and deliver measurable outcomes in transfer cycle time, method robustness, data integrity, and audit readiness.
Salary Range: $90,816-$130,000/year 10% annual bonus
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Responsibilities
- Transfers analytical methods, including risk assessment, planning, material acquisition, protocol and report approval.
- Maintains methods in compliance with legislation, standards, pharmacopeia, and corporate procedures, and performs troubleshooting as needed.
- Manages installation of new instruments and their qualification prior to use.
- Co-Ensures knowledge, implementation, and maintenance of computerized system validation in alignment with regulatory requirements, corporate standards, and pharmaceutical industry best practices.
- Ensures knowledge and implementation of ALCOA principles and data governance practices to guarantee data integrity and compliance.
- Maintains the area’s project list updated and ensures the team is aware of all project stages.
- Responsible for identifying and communicating to the manager the need for acquiring new instruments through CAPEX review, as well as assisting in planning the area’s expenses.
- Participates in project teams for new product development.
- Improves laboratory systems and procedures related to cGMP/cGLP.
- Maintains housekeeping and implements 5S principles in laboratories to ensure organization and safety.
- Interacts with the Quality Units regarding transfer and improvement of departmental methods.
- Ensures the implementation of global procedures related to the area of responsibility.
- Informs management of project status through meetings and reports.
- Plans and provides developmental opportunities for personnel to increase efficiency, encourage job satisfaction, and ensure training for potential advancement.
- Provides a stimulating environment to colleagues to increase scientific exchange.
- Maintains broad organizational contact with Regulatory Affairs, New Business Development, Quality Control,
- Quality Assurance, and external partners such as instrument suppliers and contract labs.
- BS/MS in Chemistry, Pharmacy, or related field with 6–10 years of relevant experience in a regulated industrial setting, including analytical method development and validation.
- Ph.D. with 4–6 years of relevant experience may be considered equivalent.
- Experience with HPLC/UPLC, GC, LC‑MS/MS, dissolution, spectroscopic methods, compendial testing (USP/EP/JP), stability indicating methods, sample preparation automation, data systems (Empower/Chromeleon), LIMS, ELN required.
- Leadership/soft skills: People leadership, stakeholder management, executive communication, influencing without authority, coaching, conflict resolution.
- At least 1–2 years experience leading scientists or lab operations required.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
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.
Salary : $90,816 - $130,000