Senior Manager, Drug Substance Manufacturing and Process Engineering
Tricida seeks an experienced, hands-on chemical engineer to join our rapidly expanding team in the role of 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% time
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, 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 send resumes to email@example.com and indicate Job Code PK009