Clinical Supply Chain Associate Manager – Site Supply Capabilities

Position Summary:

We are seeking a dynamic and experienced Clinical Supply Chain Associate Manager – Site Supply Capabilities to join our team. In this role, you will collaborate with a cross-functional team spanning Supply Chain, Quality, CMC Pharmaceutical Development, Regulatory, Clinical Development, Clinical Operations, CROs, and external partners. Your mission will be to ensure the compliant and efficient management of clinical trial supplies at trial sites, driving excellence and maintaining the highest standards. 

We’re looking for a motivated professional with proven expertise in any of the following areas:

• Sponsor Clinical Supply Chain Organizations within the biotech/pharmaceutical industry
• Sponsor Clinical Operations Organizations or CROs within the biotech/pharmaceutical industry
• Clinical Pharmacy Operations

Key Responsibilities Include:

1. Clinical Trial Supply Management:
• Address on-site and in-transit temperature excursions.
• Present quarterly metrics on temperature excursions.
• Oversee expiry management of clinical trial supplies.
• Conduct initial triage of clinical product inquiries from trial sites.
• Train clinical trial sites on proper handling and dosing of investigational products.
2. Documentation and Communication:
   • Directions for Handling & Administration (DHAs)
   • Information for Patient Management (IFPs)
   • Pharmacy Manuals
• Coordinate, review, and manage critical documents, including:
3. Compliance and Site Capability Assessment:
• Assess and approve on-site drug destruction methods in line with company standards.
• Assist in the drug accountability, returns, and destruction processes.
• Coordinate reverse logistics to support product complaints.
4. Training and Stakeholder Engagement:
• Interface with clinical trial site personnel and answer CRA (Clinical Research Associate) inquiries.
• Train site personnel and CRAs on company procedures.
• Develop and refine site-facing supply-related SOPs.
5. Inspection Readiness:
• Serve as a subject matter expert for temperature excursion management and pharmacy manual oversight.
• Support inspection readiness efforts across active clinical trials.

Education, Registration & Certification:

• Bachelor’s Degree in Science, Business, Supply Chain, PharmD, or equivalent experience.
• Pharmacy experience or training is highly desirable.
• APICS certification is a plus.

Experience:

• With PharmD: 2–3 years in clinical pharmacy operations.
• Without PharmD: 5–7 years in clinical pharmacy operations, Sponsor Clinical Supply Chain Organizations, or Sponsor Clinical Operations Organizations/CROs within the biotech/pharmaceutical industry.
• Specialization in ophthalmology, nephrology, compounding, or clean room operations is preferred.

Skills, Knowledge & Abilities:

• Strong knowledge of inventory management, distribution (including cold chain logistics), and reverse logistics.
• Proficiency in computer systems and software.
• Exceptional organizational, communication, and problem-solving skills.
• Ability to manage multiple projects in a fast-paced, dynamic environment.
• Motivated self-starter with the ability to work independently and collaboratively.
• Project management expertise and a track record of meeting deadlines.

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected. 

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for