Manager, Analytical Development

• Transfers analytical methods, including risk assessment, planning, material acquisition, protocol and report approval.
• Maintains methods in compliance with legislation, standards, pharmacopeia, and corporate procedures, andperforms 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 alignmentwith 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.

Requirements

• 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, LCMS/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, andwellness 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.