Sr. Manager/Manager, Drug Product Development & Manufacturing
Tricida, Inc., is a pharmaceutical company focused on the development and commercialization of its late-stage investigational product candidate, TRC101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). We are led by a management team with an accomplished and proven track record in discovering, developing and commercializing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. We recently completed a successful Initial Public Offering and our stock is listed on the Nasdaq Global Select Market under the symbol TCDA. We are expanding our existing group of exceptionally talented and well-motivated colleagues to develop and commercialize our first-in-class drug candidate, TRC101.
WE CAN OFFER YOU:
- The chance to join a successful and growing organization with an unmatched leadership team, passionate about their employees.
- An opportunity to make a real impact on chronic kidney disease patients with our cutting-edge therapeutics.
- A supportive, collaborate work environment, with colleagues who care about the success of the organization.
- A place that will treat you fairly, provide competitive compensation, on-going recognition, and most of all, a chance to learn, contribute and develop your skills.
- Fun, enthusiasm, support, a passion for healthy living and never a dull moment…
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.
- Generate and/or review Process Validation documentation, including Product Validation Master Plans, Statistical Product Sampling Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
- 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 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:
- B.S or M.S. degree in pharmaceutical science, chemical engineering, or other related scientific discipline.
- 8+ years of hands-on experience with increasing responsibility in solid oral dosage manufacturing process development. Experience with commercial manufacturing of solid oral dosage form is preferred.
- 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.
- 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.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverage, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Stock Options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday will be provided as per company policy.
Tricida is located in South San Francisco, CA.
To apply for this position, please send resumes to firstname.lastname@example.org and indicate Job Code 215.014
Tricida is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.