Logo

Expanding our team to develop and commercialize a first-in-class drug for CKD patients

Careers

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.

Job opportunities

Summary:
We seek an Associate Director, CMC Project Manager skilled in pharmaceutical late phase drug development and commercialization to support project management of our Chemistry Manufacturing and Control (CMC) activities in conjunction with internal subject matter experts and external project managers from Tricida’s CMOs.  The Associate Director will be responsible for planning and on-time completion of a variety of drug manufacturing and testing activities including the management of deliverables and ongoing risk mitigation.  The Associate Director will report to the Senior Director, CMC Project Management.  The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of drug development, preferably demonstrated with previous drug development and commercialization experience.  The position will collaborate closely with cross-functional team members, including process chemistry, drug product manufacturing, analytical chemistry, regulatory and clinical operations, to ensure timely manufacturing of drug substance and drug product, regulatory agency updates, and supply of clinical trial material.

Responsibilities Include:

  • Assist in project management efforts associated with CMC activities to support manufacturing and release of drug substance and drug product, manufacturing process improvements, analytical method development and transfer, and shipping related activities.
  • Provide project coordination and communication in support of multiple CMC projects at Tricida’s CMOs, including participation in technical calls and face-to-face meetings, development of agendas, creation of meeting minutes, tracking of action items, and scheduling of follow-up meetings.
  • Facilitate cross-functional planning of CMC activities across departments and disciplines to align dependencies, schedules, funding and delivery commitments.
  • Proactively identify potential risks, resource constraints, and conflicts that could impact project timelines; collaborate with the development team to develop appropriate solutions.
  • Schedule, conduct, and draft minutes for internal CMC team meetings and ensure regular, efficient team, and stakeholder communication.
  • Support writing, review, publication, and filing of CMC related regulatory documents and health authority interactions, including those associated with INDs, CTAs, IMPDs, NDAs, and PAIs.
  • Assist in preparing presentations, updating corporate project plans, etc.
  • Perform additional responsibilities as deemed necessary by management.

Experience & Skills:

  • B.S. degree in scientific field plus at least 7 years of experience in the biotechnology or pharmaceutical industry.
  • Minimum of 3 years’ experience in Project or Program Management at a biotechnology or pharmaceutical company with direct involvement in the CMC area.
  • Experience in a GMP environment is required; drug substance and drug product manufacturing experience preferred.
  • Strong understanding of pharmaceutical product development, including US and EU pharmaceutical regulations.
  • Experience working in cross-functional, global, virtual environments. Excellent interpersonal and organizational skills, with an ability to build relationships at all levels of the organization, including external vendors.
  • Excellent verbal and written communication skills. Demonstrated ability to influence peers and stakeholders in business and technical roles.
  • Demonstrated ability to exercise independent judgment and strategic thinking with minimal supervision.
  • Microsoft Project (or Smartsheet), PowerPoint, Excel skills are essential. SharePoint experience preferred.
  • PMP certification a plus.
  • Ability to travel up to 10%, domestic and international.

Competitive Compensation and Benefits include:  Medical, Dental, and Vision Coverages, 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.

To apply for this position, please send resumes to jobs@tricida.com and indicate Job Code 310.125

 EOE

We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Clinical Quality Assurance will provide internal and external leadership for the Tricida clinical development team through subject matter expertise, audits, and implementation of associated strategies to ensure compliance with applicable FDA and international standards, regulations and guidelines.

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…

RESPONSIBILITIES INCLUDE:

  • Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards in support of the clinical development program
  • Develop solutions to complex quality issues and work closely with senior management to prevent and resolve significant compliance issues
  • Oversee GCP Quality Assurance programs for clinical trial execution and reporting
  • Develop and facilitate GCP training for functional areas and personnel involved in the execution of clinical trials
  • Plan and manage GCP compliance audits, including but not limited to clinical investigator sites, contract clinical laboratories and CROs to determine compliance status and identify compliance risks
  • Manage the preparation of audit reports and report audit findings to management with recommendations for resolution. Verify appropriate corrective actions have been implemented and documented
  • Lead strategic Clinical QA planning and risk assessment; manage CAPA plans
  • Participate in the evaluation, qualification and selection of CROs and other clinical service providers; establish quality agreements with clinical CROs
  • Provide GCP-related subject matter expertise/guidance to the company through review of essential documents (e.g., protocols, amendments, case report forms, tables and listings, informed consent forms, investigator brochures, and Clinical Study Reports) and regulatory submissions, as requested
  • Lead inspection readiness activities. Participate in regulatory authority inspections and collaborate with Regulatory for interactions with agencies on GCP-related matters and preparation of responses to address inspection findings.

EXPERIENCE AND SKILLS:

  • Bachelor’s degree in a scientific discipline, minimum 10+ years of experience in Clinical Quality Assurance
  • Strong working knowledge of Good Clinical Practices (FDA/ICH), 21CFR Part 11 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements
  • Prior experience performing clinical-related audits and leading inspection-readiness activities
  • Demonstrated ability to manage tasks and variable workloads with demanding timelines
  • Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution
  • Must have excellent verbal and written skills
  • Strong organizational and management skills
  • Excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management
  • Position will require travel

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 will also be provided according to company practice.

Tricida is located in South San Francisco, CA and this is an on-site position.

SEND RESUMES TO: jobs@tricida.com and indicate Job Code 310.127

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.

We are currently seeking a qualified, highly motivated, experienced individual for the position of (Sr.) Director Project Manager, CMC skilled in pharmaceutical late phase drug development and commercialization to support project management of our Chemistry Manufacturing and Control (CMC) activities in conjunction with internal subject matter experts and external project managers from Tricida’s CMOs.

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…

The Director will be responsible for planning and on-time completion of a variety of drug manufacturing and testing activities including the management of deliverables and ongoing risk mitigation.  The Director will report to the Vice President Project Management.  The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of drug development, preferably demonstrated with previous drug development and commercialization experience.  The position will collaborate closely with cross-functional team members, including process chemistry, drug product manufacturing, analytical chemistry, quality assurance, regulatory and clinical operations, to ensure timely manufacturing of drug substance and drug product, regulatory agency updates, and supply of clinical trial material.

RESPONSIBILITIES INCLUDE:

  • Lead project management efforts associated with CMC activities to support manufacturing and release of drug substance and drug product, manufacturing process improvements, process validation, analytical method development and transfer, and product launch related activities.
  • Provide project coordination and communication in support of multiple CMC projects at Tricida’s CMOs, including participation in technical calls and face-to-face meetings, development of agendas, creation of meeting minutes, tracking of action items, and scheduling of follow-up meetings.
  • Facilitate cross-functional planning of CMC activities across departments and disciplines to align dependencies, schedules, budgets and delivery commitments.
  • Proactively identify potential risks, resource constraints, and conflicts that could impact project timelines; collaborate with the development team to develop appropriate solutions.
  • Conduct internal CMC team meetings and draft minutes to ensure regular, efficient team, and stakeholder communication.
  • Support writing, review, publication and filing of CMC related regulatory documents and interactions, including those associated with INDs, CTAs, IMPDs, NDAs and PAIs.
  • Assist in preparing presentations, updating corporate project plans, etc.
  • Perform additional responsibilities as deemed necessary.

EXPERIENCE AND SKILLS:

  • BS degree in scientific field plus at least 10 years of experience in the biotechnology or pharmaceutical industry.
  • Minimum of 6+ years’ experience in Project or Program Management at a biotechnology or pharmaceutical company with direct involvement in the CMC area.
  • Experience in a GMP environment is required; drug substance and drug product clinical and commercial project management manufacturing experience preferred.
  • Strong understanding of pharmaceutical product development, including US and EU pharmaceutical regulations.
  • Experience working in cross-functional, global, virtual environments. Excellent interpersonal and organizational skills, with an ability to build relationships at all levels of the organization, including external vendors.
  • Excellent verbal and written communication skills. Demonstrated ability to influence peers and stakeholders in business and technical roles.
  • Demonstrated ability to exercise independent judgment and strategic thinking with minimal supervision.
  • Microsoft Project (or Smartsheet), PowerPoint, Excel skills are essential. SharePoint experience preferred.
  • PMP certification a plus.
  • Ability to travel up to 10%, domestic and international.

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 will also be provided according to company practice.

Tricida is located in South San Francisco, CA and this is an on-site position.

SEND RESUMES TO: jobs@tricida.com and indicate Job Code 310.137

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.

We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Manager/Associate Director, Regulatory Affairs – CMC. A qualified candidate in this position will be responsible for developing, coordinating and managing CMC regulatory submissions, such as IMPDs/IND amendments, NDA/MAA and post-approval submissions. The candidate will contribute to the development and implementation of CMC regulatory strategies for late phase development and commercialization of Tricida’s polymer product.  This position will be integral in the day-to-day functioning for CMC Regulatory and will collaborate with several key groups including CMC, Quality Assurance, and Project Management.

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…

RESPONSIBILITIES INCLUDE:

  • Manage the development, review and submission of CMC filings in the US and ex-US, including IND amendments, IMPDs, annual reports and CMC sections of NDA/MAA and post-approval submissions, for the Company’s polymer product.
  • Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product.
  • Support the supply of ongoing clinical studies and commercial product.
  • Review technical reports, specifications, and other documents supporting drug substance and drug product manufacturing for adherence to regulations, guidances, commitments and strategies.
  • Represent Regulatory on project teams to outline submission requirements and define timelines for on-time delivery of high-quality regulatory CMC submissions.
  • Coordinate and prepare written responses to requests for CMC information from regulatory authorities and briefing documents for meetings with regulatory authorities.
  • Participate in CMC meetings with regulatory authorities as needed.
  • Maintain an advanced level of understanding and awareness of existing and emerging legislation and guidance related to CMC and advise project teams accordingly.
  • Provide regulatory expertise and policy support for GMP.
  • Communicate with team members and management to provide updates on regulatory activities, as needed.

EXPERIENCE AND SKILLS:

  • Bachelor’s degree in a scientific discipline, preferably in chemistry or engineering.
  • Minimum of 5 years’ experience with increasing regulatory responsibility in CMC in the pharmaceutical/biotechnology industry
  • Demonstrated regulatory experience in the preparation of CMC regulatory submissions for marketed (commercial) drug/biologic products
  • Experience with submitting documents to regulatory authorities in eCTD format
  • Strong knowledge of FDA, EU and ICH guidelines and regulations governing CMC
  • Ability to think critically, plan and implement
  • Excellent organizational, communication and interpersonal skills, including the ability to work cross-functionally in a global environment and with external vendors
  • Ability to prioritize and manage multiple projects and tasks in a fast-paced, biopharmaceutical company
  • Excellent written and spoken English
  • Proficiency in Microsoft® Office (Word, Excel, PowerPoint) and Adobe Acrobat
  • Ability to travel approximately 5%, domestic and international

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 will also be provided according to company practice.

Tricida is located in South San Francisco, CA.

SEND RESUMES TO: jobs@tricida.com and indicate Job Code 310.157

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.

Summary:

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.  

Responsibilities: 

  • 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 jobs@tricida.com and indicate Job Code PK009

EOE

Contact

Tricida Inc.

7000 Shoreline Court, Suite 201
South San Francisco, CA 94080

info@tricida.com Tel (415) 429-7800