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Venture Capital Funded (Series A) Biotech
Associate Director / Director, Combination Device and Late-Stage Drug Product Development
Summary:
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.
Essential Functions:
- Leading the Design Control process in the context of CMC requirements for 2 programs phase 3 regulatory submission content.
- Guide the DP team on the necessary technical/CMC requirements for compliance with 21 CFR Part 4 and Part 820.3 and implement into the Combination Product program plan.
- Build the required Design Control documentation with program specific content, including appropriate SOPs, DDP, Design Input/Output Requirements, URS, Verification and Validation testing protocols/reports, FMEAs etc.
- Collaborate with numerous external Team members to build the phase appropriate DHF and DMR including, Program Management, Clinical, Regulatory, QA, QC, component suppliers and DP production CMO.
- Manage suppliers of PFS components and ensure the supply chain is in place for clinical production.
- Interact with the DP Technical Team and advise on late-stage development strategies for successful execution of Process Characterization studies and PPQ campaigns.
- Support the DP Technical Team in tech transfers of the process(es) for both late and early-stage programs to CMOs.
Requirements:
- BSc or MSc in Pharmaceutics, Chemistry, Biochemistry or Engineering preferred, with >8 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biochemistry or Engineering with >5 years of relevant experience.
- The candidate should have significant experience in managing and executing Design Control programs with biological molecules for combination products, preferably PFSs.
- Experience with vaccines and/or suspension products would be a distinct advantage.
- Experience of manufacturing within GxP environments either directly or through CMOs .
- Preferred experience in late-stage DP development, designing and executing PPQ protocols, ensuring that drug product manufacturing processes are robust, reproducible, and meet regulatory requirements. This would include conducting risk assessments, identifying critical process parameters, and overseeing process validation activities for suspension DPs.
- The candidate should have a track record of working seamlessly within and across Teams and Organizations to execute the Design Control process.
- Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up studies.
- High degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate multiple projects and timelines.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Formulation and DP technical team and well as across other teams.
- Detail oriented, rigorous and excellent skills in record keeping/documentation.
- All employees require vaccination against COVID-19.
Reports to: Senior Director of Formulation & Drug Product Development
Location: San Francisco Peninsula
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $176,000 - $190,000
Biotech/Pharma:
Small Molecule/NCE
Demand Type:
No interest in collaboration for now
Expiration:
June 4, 2024
Upcoming Conference
Nov. 12th, 2022
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