Project Manager – Technical
Fresenius Kabi USA
full-time
Posted on:
Location Type: Hybrid
Location: Lake Zurich • Illinois • United States
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Salary
💰 $95,000 - $110,000 per year
About the role
- 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.
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.
Benefits
- 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.
- 401(k) plan with company contributions
- Paid vacation, holiday and personal days
- Employee assistance program
- Health benefits to include medical, prescription drug, dental and vision coverage.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmaceutical manufacturingAPI developmentGMP complianceregulatory requirementsproject managementanalytical skillsproblem solvingquality managementtechnical documentationchange control
Soft Skills
leadershiporganizational skillsplanningcollaborationcommunication