Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing CMC team to be based in St. Louis, MO or San Diego, CA. This candidate will be responsible for interacting with contract service providers to provide Project Management support.
- Contract Service Provider (CSP) Oversight
- Provide CSP project management support including communication, cost, scope, schedule, procurement, and risk/issue management.
- Actively monitor CSP performance to ensure schedule, cost, scope, and quality adherence per agreed contracts.
- Monitor/manage costs via Change Orders, Purchase Orders, and Invoices, as needed.
- Draft/review SOPs and tools for CSP oversight.
- Support selection and assessments of CSPs.
- Support generation/review of Request for Proposals, Requests for Information, Master Service Agreements, Quality Assurance Agreements, and Scope of Work.
- Quality Assurance Interface
- Work w/QA to support evaluations of vendors, materials, deviations, etc.
- Support/lead internal investigations using structured/lean 6σ troubleshooting tools (fishbone, 5 whys, FMEA, etc.).
- Support external investigations with CSPs to identify root cause or review reports.
- Support audits as a technical rep with QA, as needed.
- Regulatory Filings
- Support the vendor-specific sections of regulatory filing documents (describing manufacturing facilities, storage, etc.)
- Degree in engineering, biology, management, or related technical field. 10+ years experience with a BS, 7+ years with an MS; industry experience required.
- Project management and outsourcing experience in pharmaceutical, life sciences, or manufacturing.
- Experience with biopharmaceutical analytical methodologies and working with contract labs.
- Self-motivated with ability to work with minimal direction and operate efficiently in a fast-paced, collaborative work environment.
- Strong organizational and communication skills.
- Working knowledge in standard software including Word, Excel, and PowerPoint.
- Experience using collaborative tools like Microsoft Teams, Project, and OneNote.
- Familiarity with Lean manufacturing and/or 6 Sigma principles
- Statistical analysis proficiency for data analysis.