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: [email protected]. 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, Quality Assurance

    Position Description:
    Reporting to the Senior Director, Quality Assurance, this individual will work closely with a development team to establish and support standards for GXP compliance. The individual will have experience building and maintaining relationships with internal colleagues.
    This full-time position is an exciting opportunity to make a difference for patients and be part of a dynamic development team.

    Responsibilities and Duties:

    • Provide GXP quality assurance (QA) support activities consistent with FDA, EU and ROW requirements to support pharmaceutical and biologic development and manufacturing for clinical stage programs.
    • Provide input to the QA strategy and operational objectives. Takes ownership for achieving annual objectives.
    • Represent the QA function in CMC meetings
    • Participate and manage both the external vendor qualification program and internal audits. Conduct GMP vendor qualification audits and processes relating to clinical drug development.
    • Responsible for managing deviations, investigations, change control and OOS processes.
    • The individual will be responsible for approving master batch records and specification documents.
    • Responsible for review of QC analytical method validation/qualification protocols, reports, test methods and GMP test results to assess suitability of product disposition.
    • Coordinate and conduct batch record review and lot disposition (Cell Banks, API/DS, DP, & Labeling / packaging).
    • Be a resource as Syndax voice of Quality for GMP requirements.
    • Participate in inspection readiness preparations, corrective action responses,
    • Ensure / establish QP declaration across programs and supply chain. Ensure chain of custody for shipment of product.
    • Manage day to day emerging QA issues.

     
    Minimum Requirements:

    • BS and 10+ years of QA experience in the Life Science industry. MS preferred.
    • Minimum of 5 years of QA auditing experience with outsourced small molecule and / or biologics manufacturing vendors.
    • Experience with small molecule programs required, large molecule experience a plus but not required.
    • Proficient knowledge and direct experience with global GMP requirements.
    • Must have excellent interpersonal, organizational, and communication skills as well as the ability to work effectively and independently as part of a multidisciplinary team.
    • Must have close attention to detail and provide hands-on support for operational activities.
  • Associate Director / Director, Small Molecule Drug Substance

    Position Description:
    The Associate Director / Director, Small Molecule Drug Substance position will be responsible for phase-appropriate small molecule drug product development. 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 product 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 guidances

     
    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 guidances
    • 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
    • Business travel, domestic and international, to various company offices, suppliers, and partners as required
  • Senior Scientist / Associate Director, Translational Sciences

    Position Description:
    Reporting to the CSO, this individual will work closely with an experienced development team to drive biomarker discovery and implementation in the clinic. The role will require close collaboration with internal development colleagues and external research vendors.

    Priorities include biomarker discovery, pharmacodynamic assay development, and implementation of biomarker assessments across clinical programs. Additionally, the individual will be responsible for analysis and presentation of correlative studies and biomarker data from clinical sample testing along with oversight of sample management activities. This full-time position is an exciting opportunity to make a difference at the cutting edge of discovery and implementation in the clinic and be part of a dynamic team.

    Responsibilities and Duties:

    • Provide expertise and leadership on development and implementation of program specific assays within program timelines
    • Prioritize and coordinate assay development efforts across programs; build systems and resources for rapid sample analysis from different studies
    • Establishes collaborative relationships with academic labs to build, test, and analyze correlative data
    • Keep current with advances in bioanalytical methodologies; evaluate, assess risks, and recommend new technologies that will be useful in expanding and enhancing gene therapy applications in model systems.
    • Identify and collaborate with external CROs to support assay development, validation and testing of samples to meet timelines for nonclinical and clinical studies, provide clinical teams with validated assays for sample analysis
    • Review and finalize assay reports to ensure scientific validity and regulatory requirements, and author IND /MMA/BLA sections related to bioanalytical methods and sample analysis, sections; participate in scientific advice preparations and meetings
    • Responsible for oversight of the logistics of investigational product, clinical non-drug material supplies, and biological samples generated in the conduct of clinical studies. This may require hands-on operational activities and will require close collaboration with clinical operations. Potential for oversight of others’ work.
    • Assure that investigational product, clinical non-drug material supplies, and biological samples generated in the conduct of clinical studies are shipped, tracked and received in a timely manner from originator to receiver locations
    • Commit to help the team provide deliverables and meet aggressive timelines. Present progress of work to project and study teams, as well as management review meetings.

     

    Minimum Requirements:

    • PhD in biological sciences such as immunology, cell and molecular biology.
    • 7+ years of experience working in oncology drug development with at least 5 years in industry or in an academic translational science research setting
    • Thorough knowledge and direct experience in assay development, qualification and validation, with scientific depth to support interpretation of results
    • Experience developing assays intended use included drug PK/TK, PD, additional safety and efficacy biomarkers, immunogenicity (including but not limited to anti-drug antibodies).
    • Experience with most recent genomic / gene expression analysis techniques and bioinformatics tools
    • Demonstrated history of working innovatively and efficiently while managing multiple projects
    • Demonstrated success and desire to work with a diverse team in a fast-paced environment under challenging timelines
    • Must have excellent interpersonal, organizational, and communication skills as well as the ability to work effectively as part of a multidisciplinary team.
    • Must have close attention to detail and provide hands-on support for operational activities