Manager, Analytical Development at Fresenius Kabi USA

Wilson, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

130000.0

Posted On

15 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Development, Validation, HPLC, UPLC, GC, LC-MS/MS, Dissolution, Spectroscopic Methods, Compendial Testing, Data Integrity, Leadership, Stakeholder Management, Coaching, Conflict Resolution, Project Management, cGMP, cGLP

Industry

Pharmaceutical Manufacturing

Description

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 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. 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, 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. Additional Information 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. Fresenius Kabi (www.CaringForLife.us) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address – messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using “Fresenius-kaabi.com” which of course includes an extra “a” in “Kabi.” Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your driver’s license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at Careers@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.

Responsibilities

Lead the Analytical Development function, managing a team of analytical scientists and ensuring successful method transfers into Quality Control. Collaborate cross-functionally to resolve complex method issues and maintain compliance with standards.