POSITION DESCRIPTION: Director, Cell Therapy Manufacturing
REPORTS TO: President, Disc/Spine Division
CATEGORY: Full-time exempt
Biorestorative Therapies (BRT) develops innovative biologics, primarily involving adult stem cells. The lead therapeutic product, brtxDISC™ (Disc Implanted Stem Cells), is an autologous cell therapy for the non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease and is intended for patients whose pain has not been alleviated by non-invasive procedures and potentially face the prospect of surgery. brtxDISC is injected into the damaged disc in an outpatient procedure. BRT plans on establishing its own manufacturing facility for the production of brtxDISC for its upcoming clinical trials, which are expected to start in late 2015/ early 2016.
The Director, Cell Therapy Manufacturing will be a hands-on leader directing all personnel staffing and operational activities required for manufacturing of cellular products intended for use in human clinical trials and ultimately commercial sale. This includes responsibility for equipment, documentation, scheduling, supplies, and training of staff. The position will also be involved in process development/optimization activities as well as other development projects required for characterization of the cellular products for release (i.e. potency assay).
Essential duties & responsibilities include:
- Managing all aspects of cell therapy manufacturing including scaling the operation to support clinical trial needs as well as ultimate commercialization of the cellular products.
- Interface with R&D to advance cell therapy process development and product development activities, including establishment of a potency assay and other release assays
- Interface with clinical operations and schedule workload for team members to meet clinical trial timelines
- Perform cell therapy manufacturing procedures, if needed
- Review of batch records and other production reports
- Write SOPs and other quality procedures required for GMP production of cellular products. Follow all applicable cGxP’s and SOPs.
- Recruit staff and build the cell therapy manufacturing operation
- A minimum of 7 years of experience in biologics manufacturing in a GMP environment with a minimum of 3 years of supervisory experience
- Experience in manufacturing a cellular product preferred
- Requires a Masters Degree or Ph.D., preferably in biology or biochemistry
- Experience in establishment of successful working relationships with outside vendors
- Experience in improving manufacturing processes, including working with new technologies and instrumentation to improve costs and efficiency
- Understanding of regulatory and quality requirements for manufacturing a biologic therapeutic
- Experience within smaller, entrepreneurial clinical stage, drug development company would be preferred
- Independent, self-driven
- Strong interpersonal skills, ability to communicate clearly and influence staff at all levels
If interested, please send your resume and compensation requirements to: