St. Louis, MO; San Diego, CA; or remote work eligible
Wugen, Inc. is a clinical-stage biotechnology company developing novel “off-the-shelf” Memory NK and CAR-T cell therapies for the treatment of cancer. Our Immuno-oncology therapies address the unmet need of patients with solid tumors and hematologic malignancies. Our transformative platform provides a distinct set of advantages over other immune cells commonly used for cell therapy. We have premier research facilities in St. Louis, MO and San Diego, CA. Come join us in our pursuit to eradicate cancer.
Job Description
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.
Primary Responsibilities
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 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.)
Preferred Qualifications
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.
Salary.com Estimation for Outsourcing Manager in St. Louis, MO
$127,883 to $177,349
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