Join our growing team of individuals dedicated to collaboration, life-long learning and seeing a day in which people with cancer live markedly longer and better lives. Syndax Pharmaceuticals, Inc. offers a competitive salary and benefits package. Qualified candidates should submit their resume and cover letter with a statement of interest, availability, and experience in Word or PDF format to: careers@syndax.com. Syndax is an Equal Opportunity Employer.

Note to Recruiters – Thank you for your interest in Syndax and our recruitment opportunities. Recruiting and employment are managed through the Human Resources Department. Syndax requires that a signed agreement be in place prior to the presentation of any candidates. We ask that recruiters and agencies do not contact or solicit employees or managers in an attempt to present candidates. The company will not be obligated or responsible for any related fees to resumes that are unsolicited.

 

  • Associate Director / Director, Biologics Drug Substance

    Position Description:
    At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. We are a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. We have an opening for a biologics drug substance Associate Director/Director. The scope of the role encompasses mid to late stage antibody development and manufacturing activities including process characterization, validation, and regulatory submission writing.
    The candidate will oversee the planning and execution of outsourced antibody drug substance development and manufacturing. They will define project scope in conjunction with CMO/CROs, ensure appropriate quality and regulatory requirements are met, and ensure that timelines and budgets are on track.

    Responsibilities

    • Define and manage drug substance CMO activities. Build strong relationships with all CMO/CROs involved in the program.
    • Review Master and Executed Batch Records, release testing data and stability data.
    • Provide direct oversight and represent Syndax CMC as person-in-plant during certain critical manufacturing activities at participating CMO/CRO sites.
    • Participate in designing comparability and characterization studies and review reports.
    • Perform risk assessment for upstream and downstream activities; create and implement any remediation plans necessary.
    • Apply a science and risk-based approach for addressing deviations, investigations, and process issues.
    • Provide clear communication to functional group and project teams.

     
    Requirements

    • Ph.D. and 10 years of biopharmaceutical manufacturing experience or MS with more than 10 years of relevant experience.
    • Experienced in all aspects of antibody drug substance manufacturing and development including expression, upstream cell culture operations, downstream purification operations, process and analytical characterization, and process validation.
    • Experienced in advancing processes through clinical development to commercialization.
    • Demonstrated ability to work outside of the box and influence novel CMC and regulatory pathways to accelerate development.
    • Knowledgeable and practiced with Single Use Bioreactors for GMP manufacturing.
    • Excellent written and verbal communication.
    • Demonstrated ability to work well in a fast-paced environment.
    • Must be able to effectively manage multiple activities and problem-solve to achieve business needs.
    • Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
    • Excellent planning and project management skills.
    • Dynamic and energetic, hands on approach to challenges.
    • Business travel to various CMO/CRO sites, company offices, suppliers, and partners as required.
  • Associate Director / Director, Small Molecule Drug Substance

    The Associate Director / Director, Small Molecule Drug Substance position will be responsible for phase-appropriate small molecule drug product substance. They will define and execute strategy for synthetic route, process optimization, site transfer, scale-up, and validation. The successful candidate will bring a strong background of process development and management of external vendors.

    Responsibilities

    • Define phase-appropriate strategies for small molecule drug substance development and manufacture
    • Manage daily activities, timelines, and budgets for all API CMO/CROs to meet corporate goals
    • Monitor work performed by API CMOs, including review of protocols, reports, raw data, methods and master and executed batch records
    • Troubleshoot development and manufacturing issues as needed
    • Participate in cross-functional development teams
    • Document development appropriately via internal and external reports
    • Prepare drug substance sections of regulatory dossiers, ensuring accuracy and consistency with regulatory guidance

     
    Requirements

    • PhD degree in synthetic organic chemistry or closely related discipline required with at least 10 years of small molecule experience in CMC function in pharma/biotech organizations
    • Late stage development and commercialization experience preferred
    • Statistical DOE experience preferred
    • Extensive prior experience managing outsourced development and manufacturing
    • Understanding of cGMPs and regulatory guidance
    • Able to manage multiple internal and external activities to meet timelines
    • Strong attention to detail and problem-solving skills, as well as the ability to work in a cross-functional team environment
    • Excellent communication skills, able to work independently and collaborate with key internal and external stakeholders
    • Based in Boston area, located in Waltham office when the office is opened
    • Business travel, domestic and international, to various company offices, suppliers, and partners as required
  • Director/Sr Director Biologics Pharmaceutical Development and Manufacturing

    Position Description
    At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. We are a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. We have an opening for a Director/Senior Director leadership role for the biologics program. The scope of the role encompasses mid to late stage antibody development and manufacturing.
     

    Responsibilities

    • Lead DS and DP pharmaceutical development and manufacturing activities relating to the biologics program.
    • Hire, develop, and manage direct reports and consultants.
    • Manage budgets, contracts, and ensure timelines are well integrated with program goals.
    • Build strong relationships with all CMO/CROs involved in the program.
    • Provide both strategic leadership and exceptional operational support.
    • Collaborate with research and development and G&A functions, to accomplish program goals.
    • Serve on the project team, representing the function and aligning on priorities.
    • Prepare regulatory CMC submissions, author SOPs and technical reports
    • Ensure compliance with Syndax quality standards.
    • Provide direct oversight and represent Syndax CMC as person-in-plant during certain critical manufacturing activities at participating CMO/CRO sites.
    • Participate in designing comparability and characterization studies and review reports.
    • Perform risk assessment for upstream and downstream activities; create and implement any remediation plans necessary.
    • Apply a science and risk-based approach for addressing deviations, investigations, and process issues.
    • Provide clear communication to functional group and project teams.

     

    Requirements

    • Ph.D. and at least 10 years of biopharmaceutical manufacturing experience or MS with more than 15 years of relevant experience.
    • Experienced in all aspects of antibody drug substance manufacturing and development.
    • Experienced in advancing processes through clinical development to commercialization strongly preferred.
    • Demonstrated ability to work outside of the box and influence novel CMC and regulatory pathways to accelerate development.
    • Knowledgeable and practiced with Single Use Bioreactors for GMP manufacturing and sterile fill-finish.
    • Excellent written and verbal communication.
    • Demonstrated ability to work well in a fast-paced environment.
    • Must be able to effectively manage multiple activities and problem-solve to achieve business needs.
    • Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
    • Excellent planning and project management skills.
    • Dynamic and energetic, hands on approach to challenges.
    • Business travel to various CMO/CRO sites, company offices, suppliers, and partners as required.
  • Manager/Senior Manager SEC Reporting

    Position Summary:
    Syndax Pharmaceuticals, Inc., is actively recruiting for an SEC Reporting Manager. This position will be responsible for the preparation and filing of all external financial reporting documents and related SEC filings, supervising Sarbanes-Oxley 404b (SOX) compliance and accounting for all equity-based transactions. The ideal candidate is someone who loves challenging opportunities and thrives with strict deadlines on a consistent basis. This position reports to the Vice President, Finance.
     
    Essential Duties and Responsibilities:
    To perform this job successfully, an individual must be able to perform the following:

    • Participate in the coordination and preparation of quarterly reports (10-Q), annual reports (10-K) and current reports (8-K).
    • Supervise Sarbanes-Oxley 404b compliance.
    • Responsible for reporting and managing all equity-based transactions.
    • Responsible for reporting equity compensation.
    • Work with various personnel and departments to collect information and input into the above referenced reports; coordinate, review and collect comments on the various drafts; prepare support files; challenge the appropriateness of disclosures; complete all relevant disclosure checklists and reporting questionnaires.
    • Maintain quarterly reporting timetable and monitor progress against reporting cycle milestones.
    • Assist with technical accounting research and documentation of new policies and procedures.
    • Monitor the development and applicability of emerging accounting and reporting rules being deliberated by the SEC, US GAAP, PCAOB, or other regulations.
    • Assist with establishment, documentation, and maintenance of company accounting policies.
    • Review and, where necessary, assist with the disclosures for the separate subsidiary year-end financial statements.
    • Assist external auditors.

     
    Qualifications:
    To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
     
    Education/Experience:
    The ideal candidate will offer:

    • Bachelor’s degree in Accounting.
    • CPA with 4-6 years of financial accounting experience with Big 4 or national public accounting firm and/or industry experience.
    • Strong written and verbal communication skills.
    • Ability to work in cross functional team environment across multiple senior levels of management.

     
    Knowledge, Skills and Abilities:

    • Combination of private industry and public accounting experience.
    • Advanced technical accounting knowledge coupled with exceptional planning and organizational skills.
    • Prior experience designing, implementing, and documenting policies and procedures—in a SOX environment.
    • Experience with the following systems is preferred: Shareworks by Morgan Stanley, NetSuite and ActiveDisclosure by Donnelley Financial Solutions.
    • Experience with XBRL tagging.
  • Senior Manager/Associate Director, Data Management

    The primary objective of this position is to coordinate and complete data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. Initially, this position will support the study lead data managers on one or more studies including performing data review/query management for those studies.

    Position Responsibilities

    • Support the establishment and maintenance of Data Management plans and study-specific data quality related documents;
    • Support CRF Development and EDC validation including edit specification development and validation;
    • Perform regular in-house data review and query resolution;
    • Ensure that data management study files are properly maintained in the trial master file;
    • Support clinical data management activities for clinical trials and regulatory submission projects are completed on time and with excellent quality;
    • Collaborate well with the rest of the biometric team;

     
    Position Requirements (Skills, Knowledge, Education and Work Experience)

    • Bachelor’s degree in a scientific, medical or related field;
    • At least 5 years of experience in clinical data management;
    • Thorough understanding of clinical trials process and regulatory requirements;
    • Thorough understanding of core CDM processes and procedures generally adopted as best practices within the industry, including knowledge of CDM processes with safety laboratory data management;
    • Familiar with the regulations that govern CDM activities;
    • Good organizational skills and able to adapt to multiple priorities in a fluid environment;
    • Good verbal and written communication skills;
    • Good skills in validating EDC databases and performing data review;
    • Experience in Oncology highly desirable;
    • Ability to use PC and widely used software packages, e.g., Excel, MS Word, programming skills desirable.

     
    Note that the title will be determined based on the candidate’s experience.