Careers

Manager/Senior Manager, Clinical Supply Chain

SUMMARY:

Disc Medicine is seeking an experienced clinical supply chain professional to manage production and distribution of clinical drug product to trial sites. This is a great opportunity where the successful candidate will play a key role in strengthening clinical supply chain capabilities at Disc Medicine.

RESPONSIBILITIES:

  • Perform necessary diligence for packaging, labeling, storage, and other relevant logistics operations across sites in US and EU.
  • Serve as person in plant (PIP) for necessary GMP operations across sites in US and EU for a variety of small and large molecule candidates
  • Design and execute packaging and labelling campaign activities including but not limited to, timeline management, documentation approval, and coordination with manufacturing and packaging partners.
  • Engage with manufacturing and packaging partners ensuring clinical supplies are delivered at labeling, packaging, and clinical trial facilities without delays.
  • Manage supply planning and forecasting to ensure alignment with study timelines, resupplies, IRT set-up and timely distribution to clinical sites in US, Europe, and ROW.
  • Review Clinical Protocols and Pharmacy Manuals and ensure appropriate supply chain strategy and supply related training/instruction materials are incorporated.
  • Design, review and coordinate the approval of investigational supply label text and proofs to meet specific country language(s), translations, and regulatory requirements.
  • Liaise with appropriate internal and external parties to ensure adequate clinical study supplies are released per the applicable regulations (Qualified Person release, Certificates of Analysis/Compliance, BSE/TSE certifications, etc.).
  • Oversee a variety of logistics issues, including but not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing.
  • Manage and ensure expiry extensions are performed at depot/sites as needed to support continued use.
  • Manage the return and destruction of clinical supplies, with proper documentation.
  • Collaborate with CMC, Clinical Operations, Quality, Regulatory, and Project Management Teams to ensure alignment of program goals.

QULAIFICATIONS

  • A university degree in health sciences, life sciences or physical sciences (or equivalent) with 5+ years’ experience in the clinical supply chain industry.
  • Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), International Conference on Harmonization (ICH) Guidelines and other relevant global pharmaceutical regulations, import-export guidelines, and directives.
  • Experience with Interactive Voice/Web Response System (IXRS) design, implementation, user acceptance testing and monitoring.
  • Must be well versed with global import/export requirements and guidance documents (FDA/EMA/ICH).
  • Demonstrated understanding of the interdependencies between Supply chain, Logistics, GMP manufacturing, Quality, Clinical, and Regulatory affairs.
  • Strong problem-solving, troubleshooting, collaborative and written/oral communication skills.
  • Ability to travel domestic and international (25% of the time) to perform audits, kick-offs, and manage GMP operations (PIP).
  • Proficiency with Microsoft applications, electronic data capture systems and inventory management systems.
  • Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel.
  • Excellent attention to detail and commitment to providing accurate, high-quality work.
  • Good organizational skills and the ability to manage multiple competing priorities.
  • Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.

ABOUT DISC MEDICINE:

The people at Disc Medicine are dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by a seasoned, collaborative team of scientists and industry experts committed to innovative programs that advance the frontiers of medicine. Disc Medicine values transparency, authentic communication, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.

Interested in joining our team? Please contact us at careers@discmedicine.com

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