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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

Tricida, Inc. is an innovative development stage biopharmaceutical company, founded in 2013, focused on the discovery and development of first-in-class therapeutics for metabolic, renal and cardiovascular 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.

Summary:

We seek a highly motivated Clinical Trial Assistant (CTA) to join our team supporting management of Tricida-sponsored clinical trials. The primary focus of this in-house CTA position is to provide administrative and project specific support related to the conduct of clinical trials and archiving of clinical trial documents, including assistance with project management activities, performing administrative duties required to run the clinical program.

Responsibilities:    

  • Assist in coordination and planning of study management process.
  • Facilitate flow and maintenance of correspondence with contract service providers.
  • Participate in internal and external team meetings.
  • Set up and coordinate meetings, prepare and distribute meeting materials and meeting minutes.
  • Set up and maintain trial master file and tracking tools.
  • Assist in contacting investigative sites to provide study-specific information.
  • Assist with preparation, tracking and distribution of presentation materials.
  • Assist in review and development of clinical study documents and tools.
  • Assist in clinical trial supplies management and distribution.
  • Assist with collection of regulatory/essential documents.
  • Assist with review of clinical study data and documents for quality control purposes.
  • Prepare clinical study newsletters.
  • Provide administrative support.
  • Perform other tasks as assigned by manager.

Experience & Skills:

  • Bachelor degree in the scientific or healthcare field is preferred.
  • 2+ years of relevant work experience in the pharmaceutical industry.
  • Knowledge of medical terminology is preferred.  Proficiency in Microsoft Office suite is required.
  • Knowledge and understanding of ICH/GCP guidelines and FDA regulations is required.
  • Ability to work independently and initiative are required.
  • Excellent verbal and written communication skills to interact in a team oriented environment are required.

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.

Local Candidates only

To apply for this position, please send resumes to jobs@tricida.com and indicate Job Code 101.104

EOE

Summary:

We seek a Director, Project Management, Clinical, skilled in pharmaceutical drug development to lead project management of Tricida’s clinical activities in conjunction with internal subject matter experts, consultants and external vendors.  This position requires the ability to integrate efforts and activities in clinical, regulatory and CMC in seamless interactions with cross-functional teams, using excellent communication and providing clear direction for objectives, milestones and timelines. This position will be responsible for planning and on-time completion of a variety of activities including the management of deliverables, adherence to budget, and ongoing risk mitigation to meet regulatory timelines and to initiate and complete clinical studies.  The Director Project Management, Clinical will report to the VP Project Management. The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of drug development, preferably demonstrated with previous clinical and drug development experience.

Responsibilities:

  • Provide project coordination and communication in support of writing, review, publication and timely filing of clinical related regulatory and study site documents, including those associated with INDs, CTAs, IMPDs, and NDAs.
  • Provide clinical project coordination and communication, including facilitation of the negotiation and management of contracts and deliverables, participation in update calls and face-to-face meetings, development of agendas, tracking of action items, and scheduling of follow-up meetings with certain vendors.
  • Assist with preparation for interactions with FDA including clinical site inspections and possible FDA GCP inspections.
  • Facilitate cross-functional planning of clinical activities across departments and disciplines to align dependencies, schedules, budgets and delivery commitments.
  • Use solid understanding of business and scientific principles to help establish priorities and proactively identify potential risks, resource constraints, and conflicts that could impact project timelines; collaborate with the development team to develop appropriate solutions.
  • Provide strategic evaluation/analysis of work flow processes with strong planning and adaptation as necessary to support on time project completion.
  • Assist with scheduling of clinical project team meetings and assist with stakeholder communication, as necessary.
  • Assist in preparing presentations, including project plans, etc.
  • Perform additional responsibilities as deemed necessary by management.

Experience & Skills:

  • B.S. in a pharmaceutical discipline, with advanced degree a strong plus.
  • Minimum of 10+ years of direct pharmaceutical project management experience supporting drug development teams with direct involvement in the clinical area. This includes experience with management of CROs and external vendors.
  • Demonstrated success in managing schedule, resources and budgets for pharmaceutical development programs.
  • Strong understanding of the regulatory requirements for all phases of pharmaceutical drug development for programs with multiple global studies, including Good Clinical Practices (GCP).
  • Detail-oriented and strong ability to critically evaluate and troubleshoot complex problems and unexpected challenges, while offering timely and informed options for resolution.
  • Outstanding leadership, communication and interpersonal skills; capable of negotiating and communicating relevant information across all levels of the company, with the ability to effectively influence different functional groups at all levels of management in global and virtual environments.
  • Must thrive in a fast-paced, changing, dynamic and intense startup-like environment and be able to effectively collaborate in a cross-functional environment.
  • Demonstrated ability to exercise independent judgment and strategic thinking with minimal supervision.
  • Experience in tracking large-scale and long-term project and budget plans is highly preferred.
  • Advanced Microsoft Project, PowerPoint, Excel, SharePoint skills are essential.
  • PMP certification is 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.

Tricida is located in South San Francisco, CA.

To apply for this position please send resumes to jobs@tricida.com and indicate Job Code AL004

EOE

Summary:

As our Financial Reporting Manager, you will prepare our quarterly and annual SEC filings and evaluate business transactions for proper accounting treatment, in support of our emergence as a public company. You will work closely with all levels of our organization and manage key external relationships. You will seek to improve the effectiveness and efficiency of our quarterly reporting process and will lead investments in our team, systems and processes.

The Financial Reporting Manager’s responsibilities are to prepare the quarterly financial statements in accordance with US GAAP and SEC guidelines, ensure that technical accounting issues are researched, documented and concurred with our external auditors for proper inclusion in our financial statements and perform monthly equity accounting and development of assumptions for stock-based compensation.

In addition to financial reporting and technical accounting responsibilities, the Financial Reporting Manager assists in setting and maintaining accounting policies, and execution and creation of new processes to support efficiencies.

The ideal candidate is detail-oriented, self-motivated, team player with a strong working knowledge of US GAAP, SEC reporting and SOX regulations. The candidate should be comfortable working collaboratively in teams and independently. He or she excels when faced with new challenges and problems to solve.

 Responsibilities:

  • Streamline and coordinate the quarterly earnings process with stakeholders such as senior management, finance, accounting, investor relations, legal and external auditors
  • Prepare monthly equity accounting and valuation assumptions, along with assisting in Tricida’s transition to the E*Trade stock administration system
  • Monitor new accounting standards and SEC reporting requirements and evaluate the impact to Tricida
  • Coordinate with external auditors on accounting positions, ensuring they are informed on issues and agree on accounting positions prior to each quarter end
  • Manage finance related research projects and collaborate with cross-functional team members in delivering high quality, reliable, decision ready information to business partners
  • Ensure that accounting documentation is compiled and maintained in support of relevant legal, regulatory, and audit requirements
  • Support and assist with quarterly reviews and annual audits or any ad hoc projects as directed by management
  • Develop accounting policies and procedures to ensure proper accounting treatment and internal controls while maximizing operational efficiency

Experience and Skills:

  • Minimum of 3-6 years of experience
  • B.S./B.A. degree in Accounting, or equivalent – CPA required
  • Strong understanding of U.S. GAAP and SEC reporting requirements and experience managing external and internal audit activities
  • Strong verbal and written communications skills as well as analytical and interpersonal skills
  • Advanced Excel skills required
  • Strong organizational skills with the ability to prioritize and multitask in managing tight deadlines with follow-through and minimal supervision
  • Possess a strong work ethic and ability to be adaptable to changing responsibilities and priorities in a fast-paced environment
  • Team-oriented, collaborative, flexible and willing to adapt to changing needs and timelines

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.

Tricida is located in South San Francisco, CA.

To apply for this position, please send resumes to jobs@tricida.com and indicate Job Code 620.14

EOE

Summary:

As Manager, Regulatory Affairs, you will actively contribute to the development of Tricida’s investigational product by serving as the regulatory lead on a global clinical trial and supporting future marketing application submissions.  Your responsibilities will include coordinating clinical and nonclinical regulatory submissions, such as IND/CTA and NDA/MAA submissions, supporting new and ongoing clinical trials, and providing guidance to project teams regarding regulatory submission strategy and requirements that are consistent with current regulations, guidelines and industry standards.

Responsibilities:

  • Represent Regulatory on the clinical project team for a global clinical trial.
  • Lead the preparation and/or review of clinical and nonclinical filings in the US and ex-US, including IND amendments, CTAs, and annual or other periodic reports, and future NDA/MAA submissions for Tricida’s lead polymer product.
  • Perform regulatory review of clinical and nonclinical study documents (e.g., protocols, ICFs, IB, safety reports/narratives, and study labels) for adherence to regulations, guidelines, commitments and strategies.
  • Manage regulatory timelines for assigned projects and ensure consistency with project timelines.
  • Coordinate written responses to information requests from regulatory authorities.
  • Proactively mitigate potential risks and partner effectively and positively to solve issues.
  • Support preparation for, and participate in, GCP inspection activities and other regulatory compliance-related activities as needed.
  • Maintain an understanding and awareness of existing and emerging legislation and guidelines that may affect Tricida products and advise project teams accordingly.
  • Conduct regulatory research on competitor activity and positioning.
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures and review other company procedures, as needed.

Experience and Skills: 

  • Bachelor’s degree, preferably in a science or similar discipline.
  • 5+ years experience in the pharmaceutical/biotechnology industry including at least 3 years in Regulatory Affairs.
  • Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions for drug/biologic products, preferably in late stage development.
  • Experience with submitting documents to regulatory authorities in eCTD format.
  • Experience with NDA submission(s) a plus.
  • Strong knowledge of FDA/ICH regulations and guidelines, particularly GCPs.
  • Strategic and flexible thinker, planner and implementer.
  • Excellent organizational, communications and presentation skills.
  • Ability to prioritize and manage multiple projects and tasks with flexibility in a fast-paced biopharmaceutical company.
  • Experience working in cross-functional, global, virtual
  • Excellent interpersonal and organizational skills, with the ability to build relationships at all levels of the organization, including external
  • Ability to travel up to 5%, domestic and

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.

Tricida is located in South San Francisco, CA.

To apply for this position, please send resumes to jobs@tricida.com and indicate Job Code SM003

EOE

Summary:

The Regulatory Operations Senior Associate will support the preparation, quality check, delivery and archiving of regulatory submissions. This role will also provide document management support to the Quality Assurance department.

Responsibilities:

  • Ensure timely and high-quality electronic publication and submission of regulatory documents in eCTD format (including paper submissions, when required) to Health Authorities.
  • Provide technical expertise and perform activities related to submission documentation, including MS Word document formatting, PDF processing, managing hyperlinks and bookmarks.
  • Support reviewers and authors to understanding eCTD principles and complete compliant regulatory documents.
  • Archive and maintain communications with Health Authorities systematically while keeping in compliance with regulation and company policy, including database entry, adhering to folder structure & file naming conventions.
  • Contribute to the implementation of standards, templates, and procedures related to regulatory documents, e.g., Regulatory Style Guide. Recommend associated process improvements.
  • Interpret, implement and ensure compliance with relevant new and revised FDA/ICH regulations.
  • Manage the publishing quality control (QC) of submissions with publishers and vendors.
  • Assist in the implementation of software, e.g., publishing and electronic document managements systems.
  • Assist Quality Assurance in the organization and archiving of manufacturing, quality control and quality assurance documents, including the maintenance of the document control system.

 Experience and Skills:

  • BA/BS degree or equivalent experience
  • Minimum of three years’ experience in a Regulatory Operations function.
  • Thorough current knowledge of eCTD format and regulatory submission requirements.
  • Proficient and strong technical aptitude with electronic regulatory submission tools (e.g., MS Word, MS Excel, Toolbox, Acrobat Pro).
  • Prefer experience with the management and implementation of DocuBridge® and SharePoint.
  • Prefer working knowledge of quality assurance document control systems.
  • Exceptional attention to detail, organization skills, ability to prioritize and multi-task, while being flexible as priorities change.
  • Ability to work individually and independently, within a multi-disciplinary team, and with external partners and vendors. Has a customer service approach and is solution oriented.

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.

Tricida is located in South San Francisco, CA.

To apply for this position please send resumes to  jobs@tricida.com and indicate Job Code AL003

EOE

Summary:

Tricida seeks a hands-on individual to join our rapidly expanding team in the role of Research Associate, Drug Substance Process Engineering. The position is directed toward late-stage process development, manufacturing and commercialization of Tricida’s Phase III polymeric drug candidate.  The successful candidate must demonstrate chemical engineering expertise and an eagerness to contribute at all levels of the manufacturing process. This position will primarily work within a team of process chemists and engineers, and collaborate with cross-functional team members.

Responsibilities:

  • Support internal laboratory activities under the guidance of senior staff, including preparation of stock solutions, polymer synthesis, and polymer purification.
  • Plan individual workload in coordination with the position supervisor.
  • Execute assignments as scheduled and on time.
  • Accurately complete experiments, document work, and maintain laboratory records.
  • Work within a team of process chemists and engineers to maintain a clean and safe laboratory work environment.
  • Support continuous improvements in the drug substance development process through characterization of existing processes and identification of opportunities for improvement.
  • Deliver technical reports, progress reports and presentations to ensure alignment within the process development team.
  • Contribute to a cohesive team environment and share laboratory responsibilities.
  • Attend and participate in team meetings.

Experience and Skills:

  • B.S. in Chemical Engineering or related scientific disciplines and 2-4 years experience.
  • Detail-oriented and able to accurately and precisely execute experiments.
  • Works well with others in a team environment and demonstrates an enthusiasm to contribute.
  • Excellent written and verbal communication skills.
  • Self-directed individual who is able to work in a fast-paced and collaborative environment.

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 PK008

EOE

Summary:

We seek a highly motivated Senior Clinical Research Associate (CRA) to join our team supporting management of Tricida-sponsored clinical trials. The primary focus of this in-house Senior CRA position is working with Contract Research Organizations (CROs) and other Contract Service Providers (CSPs) to ensure conduct of Tricida clinical trials in compliance with ICH GCP Guidelines and attainment of overall clinical study objectives.

Responsibilities Include:   

  • Developing study tracking tools and processes to increase measured efficiencies of the clinical study.
  • Reviewing and developing study-related documents including but not limited to: study protocols, Informed Consent Forms (ICFs) and other patient-facing materials, case report forms (CRFs), various study plans, manuals, instructions, etc.
  • Providing oversight of CRO’s CRAs
  • Collecting and reviewing of required essential documents necessary for study initiation.
  • Review monitoring visit reports and track resolution of all action items.
  • Co-monitoring of investigative sites, ensuring site compliance with the clinical protocol and ICH/GCP guidelines and to evaluate site’s and CRO CRA’s performance.
  • Ensure appropriate documentation of all identified site and protocol-related issues.
  • Partner with and support CRO, ensuring TMF is complete and appropriately maintained.
  • Assist in site selection, study implementation and ongoing management either directly or via CSPs.
  • Partner with other departments within Tricida (Regulatory, Legal, CMC, etc.) and consultants ensuring that Tricida-sponsored clinical trials are conducted in accordance with corporate SOPs, GCP and ICH Guidelines and applicable federal and local regulations.
  • Mentoring of junior CRAs and CTAs in daily clinical operation activities.
  • Travel will comprise up to 10-20%.

Experience & Skills:

  • Bachelor’s degree in science, nursing, or equivalent with minimum of 5 years of CRA experience.
  • In-depth working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
  • Familiarity with pharmaceutical and medical terminology.
  • Risk-based monitoring (RBM) experience is a plus.
  • Experience with writing and developing departmental SOPs.
  • Experience with management and full oversight of TMF.
  • Must be able to multi-task and execute in a fast-paced, changing environment, with adherence to timelines.
  • Excellent communication skills and the ability to work well within a multi-disciplinary team.
  • Proactive, assertive, and creative problem-solver.
  • Attention to detail and meticulous follow-through, with strong organizational skills.
  • Experience with EDC platforms.
  • Microsoft Office Suite proficiency (Word, Excel, PowerPoint).

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 101.116

Summary:

As Senior Director, Quality Assurance, you will be responsible for providing current Good Manufacturing Practice (cGMP) quality oversight to drug substance and drug product manufacturing activities at Contract Service Providers. This leadership role entails managing Tricida’s quality assurance systems and activities to assure compliance with applicable regulatory standards during late stage development activities, preparation for an NDA submission and future commercialization for its polymer drug for the treatment of metabolic acidosis.

Responsibilities:

  • Provide quality oversight to manufacturing activities at drug substance and drug product contract service providers (CSP).
  • Lead resolution of quality issues with CSPs and internal teams in a timely manner.
  • Manage activities related to disposition of clinical and commercial product.
  • Manage the CSP qualification and performance monitoring program.
  • Conduct CSP and Tricida internal audits; manage and monitor the effectiveness of any resulting corrective/preventative actions.
  • Lead Tricida’s risk assessment team(s) to identify, evaluate and mitigate/eliminate quality and compliance risks.
  • Lead the transition of Tricida’s Quality System to an Electronic Quality Management System.
  • Lead the preparation, negotiation and implementation of Quality Agreements with applicable CSPs.
  • Lead cGMP regulatory pre-approval inspection and routine inspection activities (preparation, conduct, and responses) at Tricida.
  • Assist CSPs with preparation for cGMP pre-approval inspections and routine inspection activities.
  • Manage Tricida’s product quality complaint system to ensure timely review, investigation, tracking, trending and closure.
  • Establish Tricida’s system to track, trend and report quality metrics.
  • Provide periodic quality management system reviews to Tricida senior management.

Experience and Skills:

  • Minimum Bachelor’s degree in a scientific discipline, with a minimum of 10 years in QA with increasing QA leadership roles and responsibilities.
  • In-depth knowledge and full understanding of cGMP requirements (US and EU) for drugs in late-stage development and commercial stage.
  • Solid understanding of standards of practice for the manufacture of solid dosage form drugs.
  • Prior experience with implementing and/or maintaining electronic quality systems in a cGMP environment.
  • Experience with establishing validated documentation systems and a strong understanding of 21CFR Part 11 requirements.
  • Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution.
  • Must have excellent verbal and written communication skills, as well as excellent organizational skills.
  • Excellent leadership and interpersonal skills are a must to effectively interact with and influence different functional groups at all levels of management.
  • Position may require travel (up to 10%).

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.

Tricida is located in South San Francisco, CA.

To apply for this position please send resumes to jobs@tricida.com and indicate Job Code GC011

EOE

Summary:

We are currently seeking for an enthusiastic and self-motivated Senior Financial Analyst to join the FP&A team at Tricida.  In this highly visible role you will report to the Director, FP&A and partner closely with the VP of Clinical Operations and the Associate Director of SEC Reporting and Technical Accounting to meet strategic financial objectives and communicate financial results to senior leadership.  This position is primarily focused on supporting our VALOR-CKD confirmatory postmarking trial.

Responsibilities:

  • Establish strong partnerships and build trust with key stakeholders to provide analytical support and enable insights into business performance.
  • Maintains all budget tracking and accrual files for the Clinical Operations department to support a robust month end close, quarterly forecast, and various ad hoc analyses.
  • Assesses financial impacts of amendments to CRO contracts and keeps VP of Clinical Operations informed of contracts which are incurring out of scope work.
  • Reviews and tracks payments to CROs against budgets.
  • Assists with month end close by preparing journal entries and prepares quarterly documentation to support financial audits.
  • Develops and maintains various dashboarding and reporting to upper management to communicate conclusions and recommendations.
  • Provides strategic and tactical support on annual budgeting process.
  • Supports maintenance of FP&A planning tool by reconciling actuals after month end close and creating and enhancing month end budget / forecast reporting packages for business partners and Tricida leadership.
  • Performs other duties as assigned.

Experience and Skills:

  • Works with a “customer first” mindset with the ability to effectively communicate business critical needs to business partners.
  • Ability to influence and drive to consensus in a matrixed organization.
  • Adaptable to change and a willingness to take on new responsibilities as the business evolves.
  • Bachelors in Accounting or Finance, prior experience in biotech preferred.
  • CPA or CFA.
  • Minimum of 7 years of related experience.
  • Advanced skills in Microsoft Excel and PowerPoint.
  • Ability to work autonomously while prioritizing work to maintain deadlines.
  • Comfortable managing large datasets with the ability to analyze data to support conclusions and assumptions.

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 630.012

EOE

Summary:

Tricida seeks a seasoned hands-on leader to join our rapidly expanding team in the role of Senior 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.

 Responsibilities:

  • 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 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.

Tricida is located in South San Francisco, CA.

To apply for this position, please send resumes to jobs@tricida.com and indicate Job Code KB003

EOE

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

Summary:

You will be challenged in this important role and work with accomplished scientists, as you facilitate oversight of contract service providers (CSPs) engaged in drug substance and drug product manufacturing. This includes review of protocols, reports and data associated with method validations, transfers and stability studies. The successful candidate must possess strong understanding of cGMP requirements and ICH, FDA and other pharmaceutical industry regulatory guidelines.  Strong analytical skills and prior experience in root cause analysis and deviation management are required.  You will collaborate closely with cross-functional team members, including analytical development, quality assurance, process development, regulatory and clinical operations.

Responsibilities:

  • Support analytical method validations/transfers for release testing of intermediate, drug substance and drug product at CSP’s. Write/review method validation and transfer protocols and reports. Ensure technical and regulatory compliance.
  • Review data packages associated with method validation, transfer, and stability testing against established criteria. Ensure compliance with cGMP and internal SOP’s.
  • Periodically evaluate and propose improvements to existing analytical methods. Plan and conduct lab experiments to support method validation/transfer activities as required.
  • Review data package and related documentation associated with cGMP release/stability testing, deviations, change controls.  Communicate issues related to testing with CSPs.  Ensure timelines are met.
  • Assist in investigations and deviations occurring at CSPs. Plan and conduct lab experiments to identify/confirm root cause of anomalous results as required.
  • Write/review protocols and reports related to stability studies as well as prepare tables summarizing results from stability studies.
  • Establish a system for tracking and trending release and stability data for batch analysis and shelf life establishment.
  • Maintain internal change control for validated methods and regulatory documents, and assist in the change control process at CSP’s.
  • Monitor reference standard program for drug substance and related substances at CSP’s.

Experience and Skills:

  • B.S. or M.S. in Analytical Chemistry or related scientific disciplines with 10+ years experience in analytical development, with minimum of 5+ years of experience in quality control.
  • Extensive expertise in chromatographic and spectroscopic analytical techniques.
  • Hands-on experience with method development, validation and transfer in support of pharmaceutical manufacturing.
  • Working knowledge of cGMP requirements, ICH, FDA, USP and other pharmaceutical industry regulatory guidelines.
  • Detail-oriented with exceptional organizational skills.
  • Excellent written and verbal communication skills.
  • Self-directed individual who is able to work in a fast-paced environment.

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.

Tricida is located in South San Francisco, CA.

 To apply for this position please send resumes to jobs@tricida.com and indicate Job Code:  GC008

EOE

Contact

Tricida Inc.

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

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