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Terremoto Biosciences · 2 weeks ago

Director/Sr. Director, Analytical Development

South San Francisco, CA

Full-time

Onsite

Director/Executive

$235K/yr - $260K/yr

8+ years exp

Terremoto Biosciences is located in South San Francisco and is seeking a Director/Sr. Director of Analytical Development within the Technical Operations team. The role involves managing analytical development activities for small molecule programs, ensuring compliance with regulatory standards, and collaborating with key stakeholders.

Biotechnology

H1B Sponsor Likely

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

Qualification

Ph.D. in Analytical ChemistryAnalytical development experienceQuality control experienceCDMO managementRegulatory compliance knowledgeLeadership skillsOrganizational skillsCommunication skills

Required

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

Company

Terremoto Biosciences

Terremoto Biosciences is a biotechnology company leveraging the power of lysine-based covalency to develop optimized medicines.

Founded in 2021

San Francisco, California, USA

51-200 employees

https://terremotobio.com

H1B Sponsorship

Terremoto Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (4)