Director/Sr. Director, Analytical Development/Quality Control

Position Summary:

Terremoto Biosciences is located in South San Francisco and is seeking a Director/Sr. Director of Analytical Development/Quality Control within the Technical Operations team. Reporting to the Head of Technical Operations, the incumbent will be required to work flexibly across multiple small molecule programs with responsibilities including but not limited to managing all internal/external analytical development activities across various stages of development, overseeing analytical and QC activities at trusted CDMO partners and contract testing labs, ensuring compliance with regulatory standards, and working cross-functionally with key stakeholders.

Key Responsibilities:

• Act as the analytical technical lead for multiple small molecule programs
• Provide technical leadership while working with cross-functional team members
• Develop strategies and oversee the execution of analytical activities associated with both drug substance and drug product development and manufacturing, supporting clinical development, and regulatory filings
• Lead phase appropriate analytical method development and transfer, qualification and validation activities, in-process/release/stability testing, setting of specifications, product characterization, and quality control activities
• Foster and contribute to a team culture of scientific rigor, accountability, and inclusivity through the management/mentorship of internal FTEs and supporting professional development
• Effectively communicate progress (reports and presentations) regarding all drug substance/product related activities to key stakeholders both internally and externally
• Author, review, and/or approve development/stability reports, specifications, controlled documents, standard operating procedures, deviation/investigation reports, and required sections of regulatory submissions
• Travel to CDMOs for vendor assessment, troubleshooting, qualification, and/or analytical testing oversight as needed

Qualifications:

• Ph.D. in Analytical Chemistry or related field with 8 years of experience in the pharmaceutical/biotech industry with a strong track record of technical expertise, leadership, and analytical development and quality control experience across various stages of development with small molecules
• Extensive experience with the management of CDMOs and contract testing labs
• Thorough understanding and working experience of pharmaceutical drug substance and drug products concerning cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
• Strong understanding of drug development process from preclinical through late-stage development
• Strong organizational and leadership 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 $235,000 to $260,000. 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.