Terns Pharmaceuticals · 1 week ago
Senior Director, Formulation & Drug Product Development
Foster City, CA
Full-time
Onsite
Director/Executive
$270K/yr - $290K/yr
12+ years expTerns Pharmaceuticals is a clinical-stage oncology company committed to developing transformative therapies that improve the lives of patients with cancer. The Senior Director, Formulation & Drug Product Development will lead formulation strategy and execution across Terns’ portfolio, responsible for formulation design, process development, and oversight of global CDMOs to ensure timely delivery of high-quality drug products.
BiotechnologyHealth CareMedicalMedical DevicePharmaceutical
Responsibilities
Define and lead drug product development strategy for Terns’ programs
Develop robust, scalable formulations and drug product manufacturing processes that ensure product quality
Establish specifications and control strategies aligned with global regulatory and quality expectations
Serve as a scientific and technical expert in formulation challenges for investigational drugs (e.g., solubility enhancement, stability optimization, modified release, fixed dose combinations, etc.)
Lead pre-formulation activities, formulation and process development, process optimization, scale-up, clinical manufacturing, and technology transfer for solid oral dosage forms and other relevant drug products
Oversee multiple activities in parallel at globally based CDMOs, ensuring technical excellence, maintaining aggressive timelines, and reducing cost of goods
Partner with drug substance, analytical, regulatory, and quality teams to support validation activities and PPQ readiness
Support regulatory filings, queries from health agencies and regulatory interactions related to drug product development
Collaborate closely with Drug Substance, Analytical Development, Quality, Regulatory, and Clinical Supply Chain functions
Provide CMC input to global regulatory submissions and health authority meetings
Ensure reliable delivery of clinical trial supplies and transition to commercial-scale operations
Lead and mentor formulation scientists or external consultants supporting internal programs
Contribute to building a high-performing, integrated CMC organization that supports Terns’ growth to a commercial-stage company
Qualification
Required
Ph.D. or M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field
12+ years of relevant pharmaceutical industry experience, with at least 10 years in formulation and drug product leadership roles
Demonstrated success advancing small molecule compounds from clinical to late-stage/commercial stages
Expertise in oral solid dosage forms; experience with enabling technologies (e.g., amorphous solid dispersions, lipid-based systems) strongly preferred
Experience in late-stage development to support submission of NDA filing and approval
Proven track record managing global CDMOs, including technology transfer and validation
Strong knowledge of global CMC regulatory requirements (FDA, EMA, ICH), cGMPs, and quality systems
Strategic thinker with technical depth and operational execution strength
Ability to travel both domestically and internationally to CDMOs and other vendors
Excellent communication, collaboration, and vendor management skills
Comfortable in a fast-paced, entrepreneurial biotech environment
Willingness to travel up to 35%, including to CDMO and manufacturing sites for vendor assessment, qualification, audits, and manufacturing oversight as needed
Preferred
Experience with enabling technologies (e.g., amorphous solid dispersions, lipid-based systems) strongly preferred
Benefits
Bonus
Equity
Benefits
Company
Terns Pharmaceuticals
Terns Pharmaceuticals is a biopharmaceutical company that focuses on discovering therapies that will improve the global disease burden.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.15BKey Investors
Lilly Asia Ventures
2025-12-09Post Ipo Equity· $650M
2024-09-10Post Ipo Equity· $150.15M
2022-12-20Post Ipo Equity· $86.3M
Leadership Team
Amy Burroughs
Chief Executive Officer
Emil T. Kuriakose
Chief Medical Officer
Recent News
2025-12-21
Company data provided by crunchbase