Sr. Manager/Manager, Drug Product Development & Manufacturing
Tricida, Inc. is a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed therapies. Tricida’s lead investigational drug candidate, TRC101, 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. Tricida 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.
Tricida seeks a seasoned hands-on leader to join our rapidly expanding team in the role of Sr. Manager/Manager, Drug Product Development and Manufacturing. Your in-depth drug development experience and CMO/CRO interaction skills 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 Tricida’s clinical and commercial needs. This includes manufacturing, supply chain, procurement and distribution activities, as well as preparation of CMC sections for regulatory submissions.
- Provide support for production activities at the external CMOs for manufacturing drug product for supplying clinical trials.
- Review and approve master batch records, executed batch records, manufacturing deviations and investigations.
- Provide on-site technical support during on as needed basis to oversee various manufacturing/scale up/validation activities. Provide technical expertise to trouble-shoot manufacturing/packaging process issues.
- Manage internal development work to support manufacturing process development, regulatory submissions etc.
- Prepare technical reports in support of planned regulatory submissions.
- Write, review and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines.
- Assist in generating and/or reviewing Process Validation documentation, including Product Validation Master Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
- Assist in supply chain logistics for drug product manufacturing activities.
- Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Substance Development, Quality Assurance, Analytical Development and Quality Control).
Experience and Skills:
- M.S. degree in pharmaceutical science, chemical engineering, or other related scientific discipline.
- 5+ years of hands-on experience with increasing responsibility in solid dosage manufacturing process development.
- Experience in powder for oral suspension products (sachets, stick pouches) and engineering aspects of large scale processes involved in manufacturing, such as blending and packaging.
- 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 project management skills. 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% travel.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday.
Tricida is located in South San Francisco, CA.
To apply for this position, please submit resume and indicate Job Code KB001