Clinical Supply Chain Manager

2 months ago

boston, United States PepGen Full time

We are seeking an experienced and highly organized Clinical Supply Manager to join our growing CMC team. As a Clinical Supply Manager, you will be responsible for managing the clinical supply chain for clinical-stage programs and ensuring the timely and efficient delivery of clinical trial materials. This role requires a deep understanding of clinical trial supply management, strong project management skills, and the ability to collaborate effectively with cross-functional teams. The ideal candidate will have a proven track record of successfully managing clinical supply activities within the pharmaceutical or biotechnology industry.


Responsibilities:

  • Develop and execute comprehensive clinical supply strategies and plans for multiple clinical programs, ensuring alignment with study protocols, timelines, and region-specific regulatory requirements
  • Manage the end-to-end clinical supply chain, including forecasting, planning, packaging, labeling, distribution, and inventory management including necessary ancillary materials and equipment
  • Collaborate with internal stakeholders (clinical operations, regulatory affairs, quality, CMC, etc.) to ensure seamless coordination and execution of clinical supply activities
  • Establish and maintain relationships with external vendors and suppliers, negotiating contracts, managing performance, and ensuring adherence to quality standards
  • Monitor and manage clinical trial material inventory levels, track usage, shelf life dates and disposition of materials across multiple global clinical studies
  • Oversee the labeling and packaging of clinical trial materials, ensuring compliance with relevant regulations and guidelines
  • Implement and maintain robust systems and processes for tracking and documenting clinical supply activities, including batch records, shipping records, and inventory management systems
  • Monitor and analyze clinical supply chain performance metrics, identify areas for improvement, and implement corrective actions as needed
  • Provide regular inventory status updates, guidance and support to project teams regarding clinical supply chain cons


Requirements:

  • Bachelor's degree in a scientific or related field
  • Minimum of 5+ years of experience in clinical supply chain management within the pharmaceutical or biotechnology industry
  • Strong understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and relevant regulatory guidelines (e.g., ICH, FDA, EMA)
  • Experience with cold chain management for global distribution of clinical products
  • Demonstrated experience in end-to-end clinical supply chain management, including forecasting, planning, packaging, labeling, distribution, and inventory management
  • Excellent project management skills with the ability to manage multiple projects simultaneously and prioritize tasks with team and management input
  • Ability to proactively identify and address supply chain issues
  • Proficiency in specification and use of interactive response technology (IRT) systems
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners
  • Attention to detail and a commitment to delivering high-quality work within established timelines
  • Flexibility and adaptability to work in a fast-paced and evolving environment


Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.


About PepGen:

PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn.


EEO Statement

PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.


Recruitment & Staffing Agencies: PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all of our recruiting needs. Thank you.

The Scientist, Drug Substance will support the manufacturing and development of PepGen’s Enhanced Delivery Oligonucleotides (EDOs) pipeline. This role involves working closely with PepGen’s CMC team and external CMO/CRO partners to contribute to drug substance process development. The ideal candidate will bring innovative ideas and a collaborative spirit to a fast-paced, growth-oriented biotech company.

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