Apply on Employer Site

Calico Life Sciences · 2 hours ago

Director, Analytical Chemistry

South San Francisco, CA

Full-time

Onsite

Director/Executive

$270K/yr - $286K/yr

15+ years exp

Calico is a research and development company focused on understanding human aging through advanced technologies. They are seeking a Director of Analytical Chemistry to lead small-molecule analytical development, supporting programs from pre-IND to commercialization and ensuring compliance with regulatory standards.

Biotechnology

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Expertise with developing analytical techniques and specifications for immediate release oral solid dosage, extended-release oral solid dosage, parenteral, and subcutaneous delivered products

Oversee characterization and control strategies for drug substances and drug products in alignment with ICH guidelines and global regulatory expectations

Serve as the analytical lead on CMC teams, actively contribute to regulatory filings, and act as an SME for health authority questions

Lead quality control function of GMP drug substance and drug product testing

Design stability studies, interpret data, and support shelf-life justifications and post-approval changes

Collaborate cross-functionally with formulation, chemical development, quality assurance, and regulatory teams to ensure alignment and program success

Manage external contract analytical resources to ensure high-quality and timely deliverables

Develop and implement phase-appropriate analytical strategies and quality control methods

Represent the company in regulatory meetings and inspections as an analytical subject matter expert

Qualification

Analytical ChemistryRegulatory SubmissionsAnalytical TechniquesQuality by Design (QbD)Leadership SkillsCommunication SkillsOrganizational Skills

Required

PhD in Analytical Chemistry or a related field

Minimum 15 years of industry experience in analytical development of small molecule pharmaceuticals

Proven track record in regulatory submissions (NDA, MAA) and supporting global filings and inspections

Deep knowledge of ICH, USP, and other relevant regulatory guidelines

Expertise in a wide range of analytical techniques including HPLC, GC, dissolution, spectroscopy, particle characterization, and solid-state analysis

Experience with Quality by Design (QbD) principles and risk-based analytical development

Familiarity with analytical support for combination products or novel delivery systems

Experience managing external partners and driving CDMO performance

Strong leadership, organizational, and communication skills

Ability to thrive in a fast-paced, collaborative, and dynamic environment

Must be willing to work onsite at least 4 days a week

Preferred

Experience with development of analytical methods for biologics is a major plus

Benefits

Two annual cash bonuses

Company

Calico Life Sciences

Glassdoor4.1

Calico is an Alphabet-founded research and development company whose mission is to harness advanced technologies.

Founded in 2013

South San Francisco, California, USA

201-500 employees

http://www.calicolabs.com/

H1B Sponsorship

Calico Life Sciences 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 (12)

2024 (12)

2023 (7)

2022 (10)

2021 (5)

2020 (14)