THE COMPANY

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

THE ROLE

Reporting to the Director of the Supply Chain, the Senior Manager of Supply Chain will play a key role in managing the planning, coordination, and execution of activities related to procurement, labeling, packaging, distribution, shipping logistics for clinical supplies to clinical sites globally in support of the Clinical trials. The ideal candidate will have experience setting supply chain strategy and establishing and maintaining robust systems in compliance with GCP principles and regulatory guidelines.

SPECIAL ADVISORY

The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams

THE RESPONSIBILITIES

• Responsible for leadership and management of a network of suppliers and vendors.
• Establish and maintain an effective, transparent Supply Chain business processes
• Ensure that GCP, regulatory, and clinical protocol requirements are followed.
• Manage relationships with CMOs, CROs, and key suppliers including coordination, communication, technical oversight, and escalation to ensure timely delivery, shipment, and distribution of drug product and other ancillary supplies to support global clinical trials.
• Leverage Packaging, Labeling and distribution knowledge to select clinical and commercial packaging as applicable.
• Create and maintain accurate forecasts for clinical and commercial supply of DS, DP and reagents as applicable.
• Provide rolling and binding forecasts to CMOs and CROs to ensure timelines for product supply are kept.
• Performs study closeout activities including returned goods reconciliation and inventory destruction processing as applicable.
• Provides input into URS specifications of IRT systems and perform UATs as needed
• Leverage inventory management capabilities of IRT system to effectively manage study needs.
• Work with clinical operations and CMC to ensure clinical supply needs and timelines are clearly defined and adhered to.
• Track supplier performance and provide feedback and establish action plans for poor performance.
• Develop and maintain detailed inventories of materials and supplies located at the CMOs, at sites, and at depots.
• Anticipate supply chain interruptions based on industry trends and prepare contingency plans or safety stock as appropriate
• Prepare and adhere to supply chain Standard Operating Procedures and work instructions
• Drive efficiency and cost savings within the supply by identifying optimal shipment and transportation routes with attention to consolidation of labeling packaging schedules, warehousing and distribution.
• Negotiate prices for labeling/packaging operations, raw material and inventory levels with suppliers, and vendors.
• Actively participate as an advisory member of the clinical operations and product development teams, providing information and guidance on availability, timelines, and cost of supplies and materials.
• Acts as part of the team coordinating engineering changes, facility changes, new line introductions, or new product launches to ensure there is no disruption in supply.
• Identifies and support qualification of new suppliers in collaboration with other departments.

THE QUALIFICATIONS

• BS degree in a business or scientific discipline or equivalent years of experience.
• Minimum of 6-10+ years of experience in biotech, pharmaceutical or related industry or the equivalent combination of experience and education/training.
• Minimum of 3-6+ years of experience in a supply chain related role.
• International/global experience preferred.
• Experience managing complex supply chains and CMO's, CRO's and suppliers.
• Experience with supply systems like IRT/IXRS/IWVR required
• Experienced in building and managing forecasts for clinical or commercial supply chains
• Ability to effectively manage vendors globally in a GCP environment
• Deep understanding of regulatory, GDPR, data privacy and HIPA regulations, and import/export requirements
• Excellent communication skills (interpersonal, written, and verbal)
• Excellent interpersonal and negotiation skills with a proven ability to create and maintain working relationships with vendors, suppliers, shippers, and customers.
• Demonstrated organizational skills and attention to detail.
• In-depth understanding logistics, shipping validation, and industry standard supply chain practices.
• Strong analytical and problem-solving skills.
• Demonstrated ability to learn software applications related to supply chain, and proficiency in Microsoft Office Suite.
• Use to working in a diverse, high energy and fast-moving work environment.

SALARY & LEVEL

89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position is $180,000 - $195,000 and will be commensurate with experience.

THE PERKS

• Competitive health insurance coverage
• Generous PTO allowance
• 401k match
• Employee Stock Purchase Plan (ESPP)
• Commuter Benefits
• Women's forum / mentoring
• Office based in the heart of San Francisco, near plenty of shops and restaurants
• Fun opportunities to engage with co-workers in-person and remotely

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Proof of Covid vaccination is a condition of employment.

Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.