Associate Director/Director of Biologics Drug Product Development

Syndax Pharmaceuticals is looking for an Associate Director/Director of Biologics Drug Product Development

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

For the Associate Director/Director of Biologics Drug Product position, we are seeking a highly motivated, experienced technical leader to lead the parenteral drug product development of therapeutic biologics, including but not limited to monoclonal antibodies. The candidate is expected to have expertise in liquid and lyophilized formulation development for biological therapeutics for intravenous (IV) and subcutaneous (SC) dosing. The candidate is expected to have proven track of experience in early and late-stage drug product process development, scale up, technology transfer, and validation. He/she must be able to foster productive collaborations within CMC functions and with external partners.

Key Responsibilities:

• Responsible for the IV and SC drug product formulation, process development, and validation of therapeutic biologics (e.g. mAb) from early development through BLA approval.
• Responsible for drug product stability programs and shelf-life extension from the first human dose to commercial launch product.
• Responsible for defining drug product in-use instruction in pharmacy manual.
• Responsible for drug product characterization, including extractables/leachables and elemental impurities.
• Responsible for drug product process development, scale up, technology transfer, process characterization, and validation.
• Provide strong functional technical leadership and ensure timely completion of drug product development deliverables including reports and applicable quality and regulatory documents.
• Actively contribute to cross-functional CMC strategic discussions, ensuring drug product development plans are aligned with the team goals.
• Form strong alliances within CMC functions and with external partners to ensure robust and effective technology transfer and control strategy implementation.
• Evaluate and recommend new technologies to enhance fundamental protein degradation understanding and formulation stabilization strategies.
• Understand and comply with Syndax safety, quality and regulatory policies and government regulations.
  
  

Desired Experience/Education and Personal Attributes:

• Ph.D. with at 5 years of related industry experience required, or MS or BS Degree with 10 years of related industry experience required. Advanced degree in Pharmaceutical Sciences, Chemistry and/or Chemical Engineering preferred.
• Demonstrated in-depth technical expertise in formulation and drug product process development of biologics, including process scale-up from pilot plants to commercial facilities required.
• Experience with combination products development and devices required.
• 3 years of experience in technical leadership role that includes experience managing external CDMO teams with demonstrated ability to build and develop a high performing CDMO network.
• Proven experience in the generation of relevant regulatory sections of IND and BLA filing.
• Understanding of industry best practices & trends to challenge status-quo and drive change.
• Self-motivated leader with exceptional influencing, partnership, and collaboration skills to solve scientific and business problems and drive results within a matrix environment.
• Knowledge of the cGMP practices and compliance requirements.
• Excellent written, presentation, and verbal communication skills.
  
  

Location: Syndax’s corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $215,000 - $240,000.

About Syndax:

Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.