What are the responsibilities and job description for the Contractor, Drug Product position at Syndax Pharmaceuticals?
Syndax Pharmaceuticals is looking for a Contractor, Drug Product
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:
The Contractor, Drug Product position will be responsible for formulation and process development activities for one of our preclinical pipeline programs. The suitable candidate will collaborate closely with external contract development and manufacturing organizations (CDMOs) as well as internal groups including analytical and drug substance (API), quality assurance, regulatory, and supply chain. They will be a core member of the program CMC development team and communicate progress within and outside of the function.
Key Responsibilities:
About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. 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 (formerly Twitter) 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.
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:
The Contractor, Drug Product position will be responsible for formulation and process development activities for one of our preclinical pipeline programs. The suitable candidate will collaborate closely with external contract development and manufacturing organizations (CDMOs) as well as internal groups including analytical and drug substance (API), quality assurance, regulatory, and supply chain. They will be a core member of the program CMC development team and communicate progress within and outside of the function.
Key Responsibilities:
- Lead drug product development activities and define phase-appropriate strategies for small molecule drug product development and manufacture.
- Participate in developing work scope plans and identifying and selecting drug product formulation development and manufacturing vendors with required capabilities.
- Manage activities, timelines, and budgets at CDMO/CROs conducting manufacturing, testing, and packaging activities to meet overall project timelines.
- Monitor work performed by drug product CDMOs, including reviews of protocols, reports, raw data, master and executed production records to ensure consistency with project and regulatory requirements and scientific integrity.
- Work in a fast-paced environment to meet project goals and timelines.
- Troubleshoot formulation and manufacturing issues as needed.
- Participate in and collaborate with cross-functional teams to align with their timelines and advance programs.
- Document development activities reports and identify issues to address with the cross-functional team.
- Author, review and approve GMP documents for clinical supply manufacturing.
- Support any quality investigations or events and resolve them in a timely manner.
- Prepare drug product sections of regulatory filings, ensuring accuracy and consistency with regulatory guidance documents.
- Degree in a relevant scientific discipline; Ph.D. (preferred) in relevant discipline and 8 years relevant work experience or B.S./M.S. in relevant discipline and 12 years relevant work experience.
- Small molecule drug product experience required. Experience in designing and developing solid and liquid oral formulations (such as IR, MR, ODTs) and associated processes for small molecules in support of clinical and preclinical studies.
- Understanding of cGMPs and regulatory guidance.
- Experience with formulation of poorly soluble APIs and bioavailability enhancement techniques is a plus.
- Experience in designing and optimizing manufacturing processes for oral drug products.
- Able to manage multiple internal and external activities to meet timelines.
- Prior experience managing outsourced development and manufacturing.
- Strong attention to details 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 collaboratively with key internal and external stakeholders.
- Must be flexible in adapting to a changing work environment and offer solutions to program challenges.
- Business travel, domestic and international, to company office and CMOs as required.
About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. 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 (formerly Twitter) 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.
