Director, Drug Product Development & Manufacturing
Position: Director, Drug Product Development & Manufacturing
This Company is a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed therapies. The lead investigational drug candidate, represents a first-in-class approach to the treatment of metabolic acidosis, a common complication of chronic kidney disease (CKD) that can result in increased mortality, accelerated progression of kidney disease, progressive muscle breakdown and exacerbation of bone disease. This company is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. The Company is backed by world-class venture capital firms. We are expanding our existing group of exceptionally talented and motivated professionals to bring new drug candidates into clinical development.
This company seeks a seasoned hands-on leader to join our rapidly expanding team in the role of Director, Drug Product Development and Manufacturing. Your in-depth drug development experience, CMO/CRO management skills, and supply chain logistics experience will be critical in this role. You will be part of a team that will be responsible for development, implementation, and oversight of effective strategies to supply drug product for clinical and commercial needs. This includes manufacturing, supply chain, procurement and distribution activities, as well as preparation of CMC sections for regulatory submissions.
- Develop and implement comprehensive strategies for formulation and packaging development of solid dosage drug products, as well as technology transfer.
- Oversee production activities at CMOs and provide technical support and troubleshooting. Manage contract manufacturing organizations (CMOs) to produce Drug Product supply for clinical trials and commercial use.
- Manage supply chain logistics for drug product manufacturing activities.
- Provide technical expertise for manufacturing deviations, OOS/OOT investigations by working in concert with Quality Assurance to ensure proper disposition of affected materials.
- Review and approve master batch records, executed batch records, manufacturing deviations and investigations.
- Provide in-depth technical reviews for manufacturing and support CMC regulatory submissions.
- Generate and/or review Process Validation documentation, including Product Validation Master Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
- Develop budgets for Process Development & Engineering for approval by executive management.
- Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Substance Development, Quality Assurance, Analytical Development and Quality Control).
- Support operational budgets, cost controls and resource planning to meet corporate strategic objectives.
- Write, review and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines. Prepare technical reports in support of planned regulatory submissions.
Experience and Skills:
- M.S./Ph.D. degree in pharmaceutical science, chemical engineering, or other related scientific discipline.
- 8+ years of hands-on experience with increasing responsibility in solid dosage formulation development.
- Experience and in-depth knowledge in powder for oral suspension products (sachets, stick pouches) and engineering aspects of large scale processes involved in manufacturing, such as blending for formulation development and packaging.
- Successful track record in selection and management of CROs/CMOs including site qualification, technical transfer, clinical supply logistics and oversight of activities.
- Experience in writing CMC documents for regulatory submissions (IND/NDA).
- Strong understanding of pharmaceutical development, quality and regulatory issues.
- Hands on GMP experience with all phases of drug development, as well as in-depth knowledge and full understanding of GMP requirements.
- Demonstrated ability to flexibly manage tasks (directly and indirectly) and variable workloads with demanding timelines.
- Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution.
- Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management.
- Proficiency with Microsoft software (Word / Excel / PowerPoint).
- Position requires up to 10-20% travel.