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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

Accounting Manager
Job Code: SP002

Summary:

As our Accounting Manager you will manage and build our accounting team, as well as lead efforts to support 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 accounting process and will lead investments in our team, systems and processes.

The Accounting Manager’s responsibilities are to effectively perform the daily operations of the accounting department, perform monthly close process, and ensure the accuracy, timeliness, and integrity of financial data.

In addition to daily and monthly responsibilities, the Accounting Manager assists in setting and maintaining accounts payable and 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 system processes, internal controls, US GAAP and SOX regulations. The candidate should be comfortable working collaboratively in teams and independently and excels when faced with new challenges and problems to solve.

Responsibilities:

  • Streamline and manage monthly, quarterly and annual close activities by ensuring timely, accurate and complete financial records and reporting in accordance with US GAAP, legal requirements, and the Company’s corporate policies
  • Prepare and review monthly journal entries, balance sheet reconciliations, reports, and financial statements
  • Provide day-to-day leadership and support to the AP team, including ensuring proper GL coding and approving payment transactions in accordance with valid contractual arrangements
  • Responsible for oversight of the Company’s fixed assets records in accordance to the Company’s fixed asset capitalization policy, review the monthly fixed asset depreciation schedules
  • Manage assigned 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
  • Maintain the general ledger, including account and project coding system
  • Develop, manage, and build a top tier team that proactively drives process automation and works with a collaborative mentality
  • Maintain accounting system and infrastructure to scale with business growth
  • Develop policies & procedures to ensure proper internal controls while maximizing operational efficiency

Skills and Qualifications:

  • Minimum of 5-7 years of experience
  • BS/BA degree in Accounting, or equivalent – CPA preferred
  • Strong understanding of U.S. GAAP and SOX requirements and experience managing external and internal audit activities
  • Strong verbal and written communications skills as well as analytical and interpersonal skills
  • NetSuite experience preferred, and 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 SP002

EOE

Summary:

 The Associate Director of Quality Assurance will be responsible for providing quality oversight to drug substance manufacturing activities including review of executed batch records, batch release and change control processes associated with drug substance manufacturing activities. The successful candidate must possess a strong understanding of cGMP requirements and ICH, FDA and other pharmaceutical industry regulatory guidelines. The candidate will lead manufacturing investigations related to drug substance manufacturing activities and ensure their closure in a timely manner. The position will collaborate closely with cross-functional team members including process development, manufacturing, analytical development, quality control regulatory and contract service providers (CSPs).

Responsibilities Include: 

  • Provide quality oversight to drug substance manufacturing activities including review of executed batch records and subsequent batch release/disposition.
  • Ensure investigations related to deviations during drug substance manufacturing are completed in a timely manner.
  • Identify compliance risks based on review of master and executed batch records associated with drug substance manufacturing.
  • Interface with process development, manufacturing, analytical development, quality control and regulatory team members regarding change controls associated with internal and CSP operations.
  • Perform document control functions, including login, tracking, processing, review, distribution, release and archiving of documents.
  • Maintain genealogy, non-conformance and batch release summaries.
  • Assist in the preparation and review of Quality Agreements with
  • Lead and/or support internal and external CSP audits.
  • Provide training to employees on quality
  • Collect and maintain metrics to measure the health and effectiveness of the quality system and identify and implement improvements to quality systems.
  • Support FDA and other health authority GMP inspections including assisting in pre-approval inspection activities (preparation, conduct, and responses) at Tricida.

Experience and Skills: 

  • Bachelor’s degree in a scientific discipline, with a minimum of 7 years of pharmaceutical product QA responsibilities.
  • In-depth knowledge and understanding of cGMPs for drugs in late-stage development and commercial stage.
  • Understanding of standards of practice for the manufacture of solid dosage form drugs is a plus.
  • Prior experience working with CSPs.
  • Ability to maintain attention to detail, prioritize work and handle multiple assignments in a fast-paced environment.
  • Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for
  • Ability to adapt the work schedule to participate in teleconferences with CSPs in different time zones.
  • Must have excellent verbal, written and organizational
  • Must have excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of
  • Must be able to travel up to approximately 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 GC012

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 Include:

  • 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

Director, U.S. Marketing
Job Code: JVB001

Summary:

The Director, U.S. Marketing will work with the VP of Sales & Marketing and the Chief Commercial Officer to develop and implement the Launch Readiness plan for TRC101 in Metabolic Acidosis.  He/she will also lead the development of a disease educational campaign targeting nephrologists, patients and payers to increase awareness and understanding of Metabolic Acidosis.  The Director will also be responsible for leading the planning, implementation, measurement and evolution of the Speaker Bureau and marketing driven speaker programs, as well as leading the digital strategy for the brand.

 Responsibilities:

  • Support the development of the Launch Readiness plan for TRC101.
  • Lead the planning and execution of U.S. HCP speaker programs, including content development and budget allocations.
  • Lead and execute Advisory Boards to obtain insights to help guide strategic direction.
  • Support the identification and development of key thought leaders.
  • Lead digital strategy for the brand.
  • Develop promotional materials to support execution of brand and disease messages to HCP and patient audiences.
  • Provide commercial direction on sales training content.
  • Develop and execute the professional congress/convention plan.
  • Collaborate with wide range of cross-functional teams, including Legal, to ensure coordinated, compliant execution across roles and responsibilities.

Experience and Skills:

  • 10+ years pharmaceutical industry experience and a working knowledge of marketing principles, including key principles of brand management, professional promotion and the sales process.
  • Experience developing marketing strategies and tactics, with a focus on solid implementation of tactics through a combination of individual and team efforts.
  • Strong ability to manage multiple projects across functional areas, and work independently when appropriate, in teams and as a sub-team lead.
  • Experience in managing external agencies and/or vendors on a day-to-day basis and budget management.
  • U.S. product launch experience, including development and implementation of a comprehensive launch plan (disease & product positioning, physician targeting, unbranded and branded campaign development.

Preferred Qualifications:

  • Advanced degree (MS, PhD, or MBA).
  • Experience in selling specialty and/or orphan drugs.
  • Experience in marketing specialty and/or orphan drugs.
  • Experience in nephrology.
  • Experience and proven track record of developing and implementing impactful digital campaigns and initiatives.

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 JVB001

EOE

Head of US Market Access
Job Code: JVB002

Summary

The Head of US Market Access will lead the development and execution of market access and distribution strategies to support the US launch of TRC101, a first-in-class treatment for metabolic acidosis in chronic kidney disease patients.  Reporting directly to the Chief Commercial Officer, the US Market Access leader will be responsible for developing and overseeing payer strategies, pricing recommendations, contracting process and strategies, and specialty pharmacy and wholesaler plans.  Additionally, this position will lead planning and eventual build out of a best in class market access and distribution team.

 Responsibilities

  • Develop an access and reimbursement strategy aligned to the overall brand strategy for TRC101 (access objectives, brand value story, and recommendations on distribution and the potential role of contracting).
  • Assess TRC101 channel access needs; identify 3PL, trade and pharmacy channel partners; and implement a distribution model to support the successful launch of TRC101 and to ensure ongoing cost-effective channel access.
  • Assess US payer needs and conduct payer research to understand primary value drivers and requirements to ensure optimized access for TRC101 at launch and beyond.
  • Develop TRC101 payer value proposition, value dossiers, health economic and budget impact models.
  • Educate market access stakeholders on metabolic acidosis and TRC101 value proposition to secure formulary approval and optimal patient access.
  • Develop preliminary pricing and contracting strategy to support product reimbursement within the public and private sectors.
  • Design and lead payer account management and reimbursement-support operations.
  • Design and lead channel and trade account management and support operations.
  • Understand and adhere to regulatory, legal, and compliance guidelines. Partner with key stakeholders like finance and legal to ensure proper reporting obligations are met.
  • Lead organizational planning and eventual build out of US market access team in anticipation of TRC101 launch, including market access resources and requirements for successful commercialization.
  • Manage strategic advisors in support of the operations, including vendor contracts, reporting requirements, and budgets.
  • Define the metrics and ensure internal reporting of our access and reimbursement performance.

Experience and Skills:

  • Bachelors degree required and an advanced degree (e.g. MBA, RPh., PharmD) preferred
  • 15+ years of pharmaceutical/biotech experience.
  • Significant payer access, reimbursement & distribution strategy experience.
  • Strong understanding of the complex and evolving US reimbursement landscape, including reimbursement trends, private and public payer perspectives, and healthcare policy.
  • A track record of building and maintaining relationships with key stakeholders and private & public payers.
  • Has a keen sense of the policies, regulations and compliance areas that surround this function and will seek to keep the company and our customers safely within them.
  • Commercial market access launch experience (preferably for specialty oral products).
  • Account management, pricing and contracting experience.
  • Experience in nephrology preferred.
  • Combination of strong strategic thinking with the ability to execute tactical plans.
  • Demonstrated critical thinking skills and the ability to achieve results.
  • Must have experience hiring and developing successful teams.
  • Must have superior written and verbal communication skills.

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 JVB002

 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 Include:

  • 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:
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 Include:

  • 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:

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 Include:

  • 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