JOB TITLE: DIRECTOR / SENIOR DIRECTOR, SUPPLY CHAIN MANAGEMENT

DEPARTMENT: CMC

LOCATION: SOUTH SAN FRANCISCO, CALIFORNIA / REMOTE

TYPE: FULL-TIME

HI-Bio is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. We have a precision medicine approach akin to oncology and grounded in emerging human genetics. Our pipeline is strong and built through in-licensing and discovery. HI-Bio's team is made up of industry experts from science and technology. We are on a path to building the leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.

We are seeking a Director/Senior Director, Supply Chain Management who will lead and manage clinical supply chain activities for biological development candidates. The successful candidate will shape the strategy, execution and tactical operations for all clinical supply chain activities, help establish and integrate this function within HI-Bio, and work closely with cross-functional CMC and development teams to drive clinical programs. We are seeking a leader with strong external CMO management experience and the ability to liaise with CMC, clinical development and operations teams, and external suppliers.

ROLE RESPONSIBILITIES:

• Leads and manages supply planning for Investigational Product (IP) and timelines to enable clinical studies and overall development planning
• Oversee CMO activities to ensure storage, inventory management, clinical labeling packaging, and distribution to the clinical sites, including managing RFPs, contracts, SOWs, and budgeting/spending
• Responsible for oversight of IP labeling, release, distribution, and return/destruction
• Works with CMC team to help determine bulk drug needs and aligns with Clinical Operations and Development on clinical site-specific requirements
• Oversees IP shipment orders per supply plans or as requested by Clinical Study Team
• Provides CMC related input to the development of IP-related study documents including protocols, IBs, and pharmacy manuals
• Develops strategy and oversees drug return and destruction activities at CMOs
• Works within broad CMC team to develop resupply strategies based on stability and shelf-life of clinical supplies. Assesses and prepares for challenges with IP expiry dating
• Identifies potential gaps in clinical supply chain and prepares solutions for supply challenges
• Represents CMC on clinical study cross-functional teams and aligns with Clinical Operations, Clinical Development, Regulatory and other functional areas to drive programs
• Develops plans for supplying clinical study sites with ancillary and/or comparator drug
• Understands and able to operate under GMP Quality systems for supply chain scope
• Expert in Regulatory requirements and filings for drug supply elements, including labeling and packaging
• Supports logistics for transportation and shipping of bulk drug substance and drug product across global supply chain. Works closely with senior leadership to build out CMC Supply Chain organization as HIBio scales, and hires, leads and manages direct reports as needed

EDUCATION AND QUALIFICATIONS:

• Bachelor’s or Master’s degree and 10+ years of relevant industry experience within a pharmaceutical, biotech environment or relevant CRO
• A minimum of 7 years of direct experience in a CMC supply chain related function/role; experience managing biologics supply is preferred
• 3+ years of direct managerial and/or leadership experience
• Expertise in managing packaging, labeling, logistics and distribution is required
• Demonstrated experience and thorough knowledge in GMP Quality and Regulatory for CMC clinical supplies is required
• Experience with Interactive Response Technologies (IRT), and ability to work with cross- functional teams to develop specifications and support of IRT systems is strongly preferred
• Understands and able to operate under GMP Quality systems for supply chain scope
• Expert in Regulatory requirements and filings for drug supply elements, including labeling and packaging
• Experience with clinical trial study teams and aligning with Clinical Operations and Development is required
• Excellent communication and organization skills and a highly motivated disposition with the ability to adapt to the needs of a small, growing biotech

HI-BIO RECRUITING:

HI-Bio, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.

HI-Bio Inc. does not accept unsolicited resumes from any agency that we have not directly engaged on a specific role. Our managers and employees will not accept resumes sent directly from any agency/3rd party. Unsolicited resumes sent to HI-Bio, Inc. from recruiters do not constitute any type of relationship between the recruiter and/or recruiting agency and HI-Bio, Inc. and do not obligate HI-Bio, Inc. to pay fees should we hire from those resumes.