Sr. Manager/Manager, Drug Substance Manufacturing & Process Engineering
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 an experienced, hands-on chemical engineer to join our rapidly expanding team in the role of Manager/Senior Manager, Drug Substance Manufacturing and Process Engineering. The position is directed toward manufacturing and commercialization of an existing polymeric drug candidate and will report to Tricida’s head of Drug Substance Manufacturing and Development.
- Oversee production activities at CMOs and provide technical support and troubleshooting.
- Author and/or review batch records, change controls, and other technical documents.
- Provide chemical engineering solutions and technical expertise that result in sustained manufacturing consistency, robustness, scalability, improved efficiency, and reduced costs.
- Participate in late-stage process development, validation and preparation of regulatory documents.
- Participate in the design of optimization experiments including multistep syntheses, isolation, and purification of polymer drugs.
- Contribute to project team meetings with CMOs to ensure manufacturing timelines and forecasts are met.
- Work closely with manufacturing and GMP operations to coordinate project related equipment and activities.
- Provide required support to the Quality/Regulatory functions to establish, implement, maintain, and appropriately document product related process development, tech transfer and GMP manufacturing activities.
- Prepare technical reports in support of planned regulatory submissions and future process development work.
- Generate and/or review Process Validation documentation, including Product Validation Master Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
Experience and Skills:
- Degree (MS or Ph.D.) in chemical engineering.
- 5+ years’ pharmaceutical manufacturing experience.
- Strong technical background in large-scale manufacturing, late-stage process development and commercialization of APIs.
- Familiarity with state-of-the-art technology development and implementation to improve manufacturing processes and analytical methodologies.
- Fundamental understanding of GMPs, quality, and regulatory requirements.
- Proven ability to manage CMO’s to achieve goals on aggressive timelines.
- Thorough understanding of broad CMC aspects concerning the development, manufacturing, and analysis of (polymer) therapeutics.
- Experience with reviewing master batch records, executed batch records, manufacturing deviations and investigations.
- Experience with polymer chemistry, manufacturing, and handling is a plus.
- Excellent working knowledge of process safety, QbD, PAT, and DOE
- Experienced in the use of systematic investigation techniques to identify causes of process deviations, e.g., root cause analysis, 8D reporting, Kepner-Tregoe Method.
- Well-versed in the preparation of dFMEAs and pFMEAs.
- Comfortable in the use of statistical techniques to define experimental plans and interpret results. Six Sigma certification is a plus.
- Experience in developing and execution of validation protocols. Well versed in the lifecycle validation approach. Experience in all lifecycle phases of validation a plus.
- Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential
- Strong initiative and desire to work in a fast paced, team-oriented, dynamic environment
- Proficiency with Microsoft software (Word / Excel / PowerPoint)
- Position requires travel up to 10-20%
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 email@example.com 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.