2 primary programs are extremely complex biologics whereby numerous Drug Substances are presented as an adjuvanted suspension DP. The complexity of the DP necessitates careful consideration for development of a pre-filled syringe (PFS) combination product for clinical ph3 and ultimate commercial use. Company is looking for an energetic and talented individual to join our Drug Product (DP) Development team to drive the combination product through the stages required for commercial success.
This is an SME position which is suited for someone who has significant late-stage experience in leading the technical combination product workstream for a PFS/Biologic combination product. Experience with combination product Design Control requirements and generation of completed Design Control documentation is required. As a core member of the DP Technical Team they will work closely with internal Technical and CMO/QC/QA/Clinical Teams to ensure the appropriate Device Design requirements, including Verification and Validation Testing are met for use of the combination product in ph3 clinical studies and marketing applications. They will work closely with the Regulatory and Quality Teams to ensure the appropriate 21 CFR Part 4 and 820.3 compliant documentation is produced to support both clinical studies and marketing applications.
In addition, there will be future scope for this individual to be involved in additional late-stage development activities of the DP program(s). This may include down-scale Process Characterization planning and execution, in-house Pilot scale production(s) and at-scale PPQ planning and execution. In addition, phase 3 DP campaign preparation, scale-up activities, and management of GMP productions at the DP CMO could be foreseen.
This is a unique opportunity to be involved in arguably the most complex Drug Product to enter clinical testing, be a crucial part of ph3 enablement and long-term commercial success of the product, which will affect millions of lives globally.
Reports to: Senior Director of Formulation & Drug Product Development
Location: San Francisco Peninsula
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $176,000 - $190,000