Job Summary
The Project Manager is responsible for managing product lifecycle and providing technical support for Third Party Manufacturing (TPM) projects related to project/product improvements, changes, validations, and commercial manufacturing. Manages supplier change notifications and evaluate potential impact to Fresenius Kabi systems and documentation. Collaborates with cross functional teams to resolve Technical, Regulatory and Compliance issues as it relates to TPM. Provides technical leadership and proactive involvement in external and internal meetings. This role reports to the Vice President – Third Party Manufacturing.
*This position requires working onsite 3 days per week at our U.S. headquarters in Lake Zurich, IL.
*This position is not eligible for visa sponsorship either now or in the future.
• Salary Range: $95,000-110,000.
• Position is eligible to participate in an annual bonus plan with a target of 10% of the base salary.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Responsibilities
- Provide strong leadership for TPM commercialized products to ensure finished drug products are in compliance with current GMP and regulatory requirements.
- Work closely with Third Party Manufacturing Organizations and/or Suppliers to successfully manufacture and release commercial and validation/launch batches.
- Evaluate, review and approve external change controls for TPM.
- Review TPM product validations to meet minimum compliance requirements for FK ANDA or when applicable.
- Review and approve methods, specifications, and artwork for TPM products.
- Create and maintain Technical Documents for all products at each CMO.
- Lead continuous improvement initiatives to update Standard Operating Procedures (SOPs).
- Collaborate with CMOs and Regulatory on evaluating product shelf-life extension.
- Lead TPM technical assessments and ad hoc project management (including Transportation studies, improve current processes, etc.).
- Manages internal and external resources to complete projects related to TPM and to meet current GMP and regulatory requirements.
- Act as a technical liaison between CMOs and internal FK teams to complete projects, come to resolutions, and support TPM product releases.
- Support Product Launches, business integration/acquisition activities based on business needs.
Job Requirements
- Bachelor’s in science degree required. Master’s in science degree preferred.
- 8+ years background in Chemical Engineering/Chemistry related to pharmaceutical processing / manufacturing.
- Strong technical background in pharmaceutical manufacturing and API development.
- Must have excellent analytical, problem solving, organizational, planning, project and quality management skills.
- Proficient computer skills.
- Proven experience with project management concepts.
- Ability to travel 10% of time to Third Party Manufacturing sites.
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.