Reports to: Senior Director, Chemistry, Manufacturing, & Controls (CMC)
Who we are:
If you’re looking for a typical biotechnology company, you’ve come to the wrong place.
We are a revolutionary biotherapeutics company and our mission is to revolutionize autoimmune and allergic disease treatment by resetting the immune system for superior long-term disease remission.
By developing therapies that achieve superior long-term disease remission from less frequent chronic dosing and without suppression of the immune system. A goal that others haven’t been able to reach.
Existing therapies for autoimmune and allergic diseases require frequent chronic dosing, provide only short-term disease remission in a limited number of patients and suppress the immune system, ultimately putting patients at risk of developing serious infections and life-threatening side effects.
How you’ll contribute:
Reporting to the Senior Director of CMC, the Manager/Senior Manager, Clinical Supply will help lead and manage the clinical supply needs of Revolo’s development programs. This position will work cross-functionally with internal personnel, vendors, and contract research organizations (CROs) to manage the packaging, labeling, storage, and distribution activities. The successful candidate will be skilled at understanding the needs of time sensitive programs with the ability to manage workload and meet project timelines.
Principal Duties and Responsibilities:
- Lead all activities related to packaging, labeling, storage, and distribution of clinical drug supplies to depots and investigator sites.
- Forecast supply to meet program objectives.
- Lead operational meetings with vendors and CROs and serve as the primary contact for inventory control and distribution activities.
- Manage IRT requirements, user acceptance testing, and troubleshoot issues through collaboration with vendors and CROs.
- Release supplies in the IRT and track study status to ensure supply availability at investigator sites.
- Procure import licenses and other related documents.
- Develop budget and timelines based on clinical trial design and development plans.
- Work with Quality Assurance to qualify vendors for supply activities.
- Review and update regulatory filings pertaining to stability data, retest dates, and label text.
- Support the CMC team with other supply chain activities, as requested.
Minimum Education, Training, and Experience Required:
- BS degree in a science-based subject or equivalent experience.
- 5+ years of clinical drug supply management.
- Experience with clinical supply planning and forecasting.
- Experience managing clinical trials and IRT/IxRS systems.
- Working knowledge of GMP processes as well as experience with international labeling, shipping, and import/export of clinical supplies.
- Strong understanding of clinical trial management requirements from primary packaging, finished goods, and final distribution to investigator sites is desirable.
- Demonstrated proficiency with word processing, spreadsheet, database, and presentation software.
This position requires extended periods of sitting and working on a computer. Must have the ability to navigate travel both internationally and domestic.
Revolo Biotherapeutics is an Equal Opportunity/Affirmative Action Employer – EOE Minorities/ Females / Protected Veterans / Individuals with Disabilities.