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.
  • Director, Statistical Programming

    Reporting to the Head of Biometrics, the Director of Statistical Programming serves as the Head of Statistical Programming and provides leadership and support to project teams on all programming matters. Lead an effective team to deliver study milestones from start-up to regulatory submission and approval. Collaborate with the clinical team to ensure quality and timely delivery of data analysis for in-house and out-sourced clinical trials. Key contributor to the Biometrics vision/mission.

    Responsibilities:

    • Provide technical and strategic leadership to all projects/studies
    • Act as an integral member of project team. Attend project team meetings, work with Biometrics vendor, biostatistician, data manager, medical lead, clinical trial manager and other functions to meet project deliverables and timelines
    • Manage all programming activities, including timeline and resource planning
    • Lead the programming team and Biometrics vendors to produce SDTM/ADaM dataset, TFLs and supporting documents
    • Provide review and input to study documents and processes (such as Statistical Analysis Plans, eCRFs, SOPs, etc.)
    • Ensure the programming team follows good programming practices and adequately documents programs
    • Understand and follow FDA regulations which affect the reporting of clinical trial data
    • Develop and/or contribute to data collection, analysis and reporting standards content and processes
    • Participates in cross functional task forces and initiatives
    • Mentor junior level staff in programming practices

     
    Qualifications:

    • Master’s degree in Statistics, Computer Science, Mathematics, Engineering or related discipline
    • At least 10 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry
    • Excellent technical skills
    • Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
    • Ability to communicate technical concepts clearly and concisely to non-technical colleagues
    • Strong organizational skills, attention to detail, and self-motivated
    • People management experience
    • Vendor management experience
    • Familiarity with coding dictionaries
  • Director/Sr Director, Regulatory Affairs (CMC)

    The Director of Regulatory Affairs (CMC) provides regulatory leadership in support of the development programs at Syndax. The focus for the person in this role is on the CMC aspects of the development of small molecule and biological programs. The successful candidate will provide the strategic guidance for global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life cycle of approved products. This includes developing and implementing the strategic plans in collaboration with the Quality Assurance and Pharmaceutical Development Teams, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.

    This person represents the regulatory function on multi-disciplinary CMC product development teams and with external entities. The person in this role serves as a resource to CMC team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through to the initial marketing application, and life cycle management.

    Responsibilities

    • Lead all CMC regulatory affairs activities for designated programs in line with US, European, ICH, and other applicable requirements.
    • Coordinate with Quality Assurance, Pharmaceutical Development and other functional areas to implement CMC regulatory strategy.
    • Act as the primary representative with external consultants for CMC matters.
    • Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support clinical trials and marketing applications.
    • Represent the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks.
    • Ensure that regulatory documents are accurate, complete and verifiable against source documents to confirm compliance with regulatory requirements and traceability.
    • Evaluation of manufacturing processes and changes, assessment of regulatory implications and supporting their implementation.
    • Maintain current knowledge of the relevant guidelines and regulations and determine applicability to Syndax activities.
    • Contribute to and participate in health authority meetings.

     
    Requirements

    • A bachelor’s degree in a life science, an advanced degree is preferred.
    • At least 8 years of CMC regulatory affairs experience; small molecule and biologics experience required.
    • Knowledge and understanding of global regulatory regulations and guidelines.
    • Previous experience in the preparation and submission of the CMC components of IND/CTA/NDA/MAAs
    • Strong interpersonal skills and the ability to deal effectively with representatives across disciplines.
    • Ability to work in a cross-functional team environment and manage competing priorities.
    • Strong attention to detail and excellent organizational, computer, and documentation skills