Job Summary

The experienced professional is responsible for leading clinical and commercial supply chain activities within the Technical Operation division.  Key responsibilities include demand planning, establishing and maintaining supplier relationships, and distribution for clinical and commercial supply chain activities. The Vice President will also be a key member of the Technical Operations leadership team, and accordingly, is expected to have a high degree of visibility and impact across the organization. The Vice President will report directly to the Chief Technical Officer.

The ideal candidate will have prior experience leading commercial supply chain and product launch activities within a biotechnology company. The candidate will also bring a strong strategic mindset, lead contract negotiations, and have a global understanding of region-specific requirements for the supply chain. The individual in this role will be an important contributor to establishment of the commercial manufacturing strategy, collaborating with the CTO, and senior leaders across the organization.

Job Responsibilities

• Devise and facilitate the S&OP process for Akero products. Work closely with clinical and commercial organizations to understand global product forecast, create simulations, and recommend associated capacity reservations at manufacturing sites.
• Ensure a robust, end to end, supply chain of packaged and labeled commercial combination product is implemented and maintained with appropriate business continuity measures.
• Build and foster strong collaborative partnerships with CDMOs for routine manufacturing activities of clinical and especially commercial supplies with appropriate Key Performance Indicators. Suppliers include drug substance, product, device assembly and distribution to 3PL
• Lead procurement and contract negotiations for agreements with all suppliers and storage facilities in the supply chain.
• As needed, review or facilitate review of product specifications, change controls, master batch records, plans, protocols, reports, and deviations.
• Manage logistics and inventory associated with warehousing, shipping, import, and export of materials as required through the supply chain including transport validation and temperature excursions.
• Support quality assurance in activities required for lot release of clinical and commercial batches.
• As required, author, review, and approve global health authority dossier sections for clinical trials and commercial licensure.
• Interface with quality assurance to establish and maintain procedural documents.
• Lead the establishment and periodic review of the business continuity plan including identification of risks in the supply chain with appropriate contingency planning for mitigation.
• Ensure that all supply chain activities comply with industry regulations and standards, including Good Manufacturing Practices (GMP) and Good Distribution Practices.
• Monitor and control supply chain costs to optimize budget and improve profitability.

Qualifications

• 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.

Requirements

• BS/MS in engineering, supply chain/logistics or a related discipline is required.

Compensation

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. 

  Pay range: $305,000 - $325,000 per annum

Special Advisory 

Akero will not conduct interviews via text message or messaging platforms.  Please be vigilant in checking that the communication is, in fact, coming from Akero. If you are contacted by any individual or group using email addresses or other contact information that incorporates “akerotx” but do not use our exact domain, akerotx.com, please submit a report to the FTC.