Senior Manager, Diamond Sourcing Commodity
Signet Jewelers
Assembly
Vice President, Supply Chain
Akero Therapeutics
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $305,000 - $325,000 per year
Job Level
Lead
Tech Stack
Assembly
About the role
- Lead clinical and commercial supply chain activities within Technical Operations and report to the Chief Technical Officer.
- Devise and facilitate the S&OP process; work with clinical and commercial teams to understand global product forecast, create simulations, and recommend capacity reservations.
- Ensure robust end-to-end supply chain of packaged and labeled commercial combination product with business continuity measures.
- Build and foster collaborative partnerships with CDMOs for manufacturing of clinical and commercial supplies and establish KPIs; suppliers include drug substance, product, device assembly and distribution to 3PL.
- Lead procurement and contract negotiations for agreements with all suppliers and storage facilities.
- Review or facilitate review of product specifications, change controls, master batch records, plans, protocols, reports, and deviations as needed.
- Manage logistics and inventory for warehousing, shipping, import/export including transport validation and temperature excursions.
- Support quality assurance for lot release of clinical and commercial batches and interface with QA to establish and maintain procedural documents.
- Author, review, and approve global health authority dossier sections for clinical trials and commercial licensure as required.
- Lead establishment and periodic review of business continuity plan; identify risks and contingency planning for mitigation.
- Ensure compliance with industry regulations and standards, including GMP and Good Distribution Practices.
- Monitor and control supply chain costs to optimize budget and improve profitability.
Requirements
- 20+ years relevant industry experience, preferably with both biotechnology and pharmaceutical companies.
- Experienced in leading supply chain, contract negotiations, serialization, and inventory management using external contract partners.
- Understands quality aspects of biopharmaceutical manufacture, inventory management and distribution.
- Excellent communication skills (both verbal and written) and interpersonal skills are required.
- Works on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
- Demonstrates technical proficiency, creativity, collaboration with others and independent thought in suggesting experimental design and strategy.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- Demonstrates collaborative communication and problem-solving spirit.
- BS/MS in engineering, supply chain/logistics or a related discipline is required.
