Manager, Clinical Supplies – GlycoMimetics, Inc. – Rockville, MD, USA
The Manager, Clinical Supplies will ensure delivery of clinical supplies to domestic and international clinical study sites according to clinical development plans. Responsibilities include forecasting clinical supply demands, managing inventory to meet demands, identifying and overseeing contract packaging vendors, maintaining cold chain requirements, and ensuring labelling and distribution meet applicable regulatory standards. Works independently. This position reports to the Vice-President, Technical Operations.
Defines and consolidates a supply strategy to ensure adequate and sufficient forecasting for raw materials, intermediates, API and drug product. Interacts with Clinical Operations, CMC, Quality Assurance and Regulatory to ensure adequate clinical supplies are manufactured and are available for trials
Develops clinical packaging plans to encompass supply of drug product and ancillary supplies to clinical sites, shipment of biological samples to central lab and analytical labs, return/reconciliation of clinical supplies and return/long term storage of biological samples.
Communicates clinical packaging plans to contract packaging vendors, and ensure effective management of clinical packaging vendor activities. Ensures that labeling, packaging and shipment of supplies is done on time and adheres to FDA/EMA GMP guidelines.
Tracks inventory (in- house and at CMO) including clinical supplies and raw materials. Maintains up-to-date status records and reporting for all clinical supply-related activities across projects / products
Evaluates vendor reliability; develops new supply sources, as required, in which current vendors and suppliers are inadequate. Audit vendors when appropriate
Oversees all aspects of international shipping of high value raw materials, finished products, and clinical samples, maintains cold chain, and works with customs broker to ensure international customs regulations are followed
Manages inventories at depots and sites and ensures on-time delivery with minimal overage of clinical supplies
Prepares various technical operations documents including: IND/CTA sections, SOPs, MSDs’, shipping forms, statement of use, TSCA, etc.
Analyzes manufacturing and non-clinical data; creates graphs and presentations; reviews toxicology and clinical study protocols as needed to develop supply/shipping strategy
Complies with all applicable policies regarding health, safety, and environmental policies
BS in life sciences or related area and at least 8 years of experience in a clinical supplies function with 3 years of leadership experience in a biopharmaceutical organization.; or equivalent
Experience leading clinical supplies planning and logistics activities for early and late stage global clinical trials as well as experience in label and packaging design development
Demonstrated knowledge of FDA/EMA/GMP/ICH/EU guidelines
Results oriented with ability to resolve critical technical issues utilizing knowledge, experience, and problem solving skills
Ability to communicate effectively, verbal and written. Able to successfully communicate with Clinical Manufacturing Organizations and various individuals/departments within the Company
Detail oriented with strong organization and planning skills
Strong working knowledge of standard business software, including MS Excel, Word, and PowerPoint
Ability to work both independently, and in a team environment
Ability to travel approximately 10%
Job Type: Full-time
- Biopharmaceutical: 8 years