Director, Drug Product Development

Position Summary:

Terremoto Biosciences is located in South San Francisco and is seeking a Director responsible for formulation development and drug product manufacturing within the CMC group. Reporting to the Head of CMC, the incumbent will be required to work flexibly across multiple small molecule programs with responsibilities including but not limited to managing formulation development strategies across various stages of development, overseeing manufacturing activities at trusted CDMO partners, and ensuring an uninterrupted supply of bulk drug product.

Key Responsibilities:

• Act as the drug product technical lead for multiple small molecule programs

• Develop strategies and oversee the execution of activities associated with drug product development and manufacturing, supporting clinical development, and regulatory filings

• Provide technical leadership while working with cross-functional team members

• Lead pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, and process optimization activities related to solid oral dosage forms

• Travel to CDMOs for vendor assessment, qualification, and/or manufacturing oversight as needed

• Effectively communicate both written and verbally all drug product related activities to key stakeholders

• Author development reports, compile documentation, and draft sections for regulatory submissions

Professional Experience/Qualifications:

• Ph.D. in Pharmaceutical Sciences or related field with 8+ years of experience in the pharmaceutical/biotech industry with a strong track record of technical expertise, leadership, and drug product development experience across various stages of development with small molecules

• Direct experience with the management of CDMOs

• Thorough understanding and working experience of pharmaceutical drug products concerning cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements

• Strong understanding of the drug development process from preclinical through late-stage development

• Strong organizational skills with the ability to effectively manage multiple priorities and clearly communicate results both written and verbally

• The anticipated salary range for candidates who will work in South San Francisco, CA is $220,000 to $235,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.

We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.