200 Inner Belt Road
Clinical Supply Associate at OpenBiome
OpenBiome is a nonprofit stool bank, expanding clinical access to fecal transplants and catalyzing research on the human microbiome. Fecal microbiota transplantation (FMT) is a promising new therapy for C. difficile, the most common hospital-acquired infection in the country. OpenBiome provides microbiota preparations to clinicians performing FMT, and supports clinical trials and basic research investigating new applications of microbiome-based therapies.
Five years ago, OpenBiome started the first public stool banking service, and we have grown to redefine the standard of care for this emerging field. Today, we support FMT programs at over 1000 medical centers across all 50 states and 7 countries, and have delivered over 30,000 treatments for recurrent C. difficile patients. We have also developed a new oral formulation for delivering FMT, published dozens of scholarly works and have supported over 30 clinical studies to identify new applications for FMT. As the leader in this exciting new field, OpenBiome is uniquely positioned to continue to expand access to care and discover new applications for microbial interventions. We are searching for passionate teammates eager to support this mission.
We are looking for a full-time Clinical Supply Associate (CSA) to oversee supply chain management practices across our FMT clinical and research programs. Reporting to the Director of Clinical Research Operations, the CSA will work with the teams that provide clinicians and clinical researchers with FMT preparations to forecast material needs and monitor actual usage across each program. The ideal candidate will have a background in supply chain management, operations management, or a related field. He or she will exhibit strong organizational skills, excellent technical competence, and will be self-motivated, mission-driven, a quick learner, and detail-oriented. This is a full-time, exempt position with a comprehensive benefits package.
Position Responsibilities / Duties:
- Collaborating with Clinical Outreach and Clinical Research Operations teams to assure timely and thorough inventory planning and forecasting of FMT preparations used by our partner clinicians and investigators
- Analyzing material production needs across the organization and determine and set production levels and schedule, and monitor usage against forecasted demand
- Reconciling monthly/quarterly inventory in stock with completed shipments
- Liaising with CSA counterpart at Finch Therapeutics Group, OpenBiome’s licensed manufacturer of FMT products, to place production orders and serve as a contact to troubleshoot delays in ordering and shipping of material
- Managing programs aimed at the continual improvement of production/inventory control systems, and ensure these programs comply with FDA regulations, Good Clinical Practice (cGCP) guidelines, and Good Manufacturing Practice (cGMP) guidelines
Minimum educational and work experience qualifications:
- BA/BS degree and 1-2 years of experience in clinical research or inventory and logistics planning
- Must be legally eligible for work in the United States
Preferred educational and work experience qualifications:
- BA/BS degree in Supply Chain Management, Operations Management, or a related field
- 1-2 years of experience in inventory planning, production control, and/or supply chain management and shipping logistics in a healthcare or biotechnology setting
- General knowledge of drug development and clinical trials
- Knowledge of FDA regulations, Good Clinical Practice (cGCP) guidelines, and Good Manufacturing Practice (cGMP) guidelines
- Strong demonstration of analytical thinking and problem solving
- Ability to multi-task and manage multiple deadlines simultaneously
- Highly detail-oriented and organized
- Very strong writing and editing skills
- Open to receiving both formal and informal feedback
- Passion, humility, and excitement for doing whatever it takes to meet a great public health need
OpenBiome is an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Minimum Education Required
How To Apply
To apply, please go to www.openbiome.org/jobs and submit your Cover Letter and Resume.