Director, Analytical Development and QC
Apply NowCompany: Iambic Therapeutics, Inc
Location: San Diego, CA 92154
Description:
JOB SUMMARY
Iambic Therapeutics is seeking a Director, Analytical Development to join our growing CMC team. This leadership role will oversee analytical method development, method transfer/validation, quality control, and stability testing for critical raw materials, intermediates, drug substance and finished drug products within Iambic small molecule programs. The role will serve as the lead Analytical Development point of contact to all key internal stakeholders and external stakeholders including contract service providers, ensuring that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (including GLP and cGMP).
KEY RESPONSIBILITIES
QUALIFICATIONS
ABOUT IAMBIC THERAPEUTICS
Founded in 2019 and headquartered in San Diego, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai.
MISSION & CORE VALUES
The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life Insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
Iambic Therapeutics is seeking a Director, Analytical Development to join our growing CMC team. This leadership role will oversee analytical method development, method transfer/validation, quality control, and stability testing for critical raw materials, intermediates, drug substance and finished drug products within Iambic small molecule programs. The role will serve as the lead Analytical Development point of contact to all key internal stakeholders and external stakeholders including contract service providers, ensuring that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (including GLP and cGMP).
KEY RESPONSIBILITIES
- Lead the Analytical Development activities within CMC, designing and executing phase-appropriate analytical strategies, including analytical method development, specification justification, and reference standard characterization, to enable drug substance and drug product batch release.
- Provide analytical technical support for drug substance and drug product manufacturing during preclinical, clinical, registrational, and validation stages.
- Serve as SME (subject matter expert), authoring analytical sections of Module 3 for regulatory filings (IND, IMPD, NDA, MAA, etc.).
- Lead analytical method transfers and validations for drug substance and drug product (enabling and conventional oral solid dosage forms) at CDMOs/CROs, supporting technology transfer, and providing hands-on support as needed.
- Manage external contract analytical release and stability testing sites. Actively communicates product quality risks and trends.
- Collaborate effectively with cross-functional teams, aligning strategies to support the clinical development of Iambic's programs.
- Develop and implement Standard Operating Procedures (SOPs), processes and systems relevant to Analytical Development function.
- Manage budget proposals and contribute to the annual budgeting of CMC.
QUALIFICATIONS
- Ph.D. in analytical chemistry or a related filed with 10+ years of experience in the pharmaceutical/Biotech industry (or an M.Sc. with 12+ years or B.Sc. with 15+ years of experience).
- Extensive hands-on experience in analytical method development, transfer, troubleshooting, and validation of small molecule drug substance (DS) and drug product (DP) in both early and late-stage development.
- Proven track record in managing external analytical testing sites.
- Demonstrated ability to work effectively in diverse, cross-functional teams and excel in a fast-paced environment while managing multiple priorities.
- In-depth knowledge of GLP. cGMP, worldwide regulatory requirements, and current industry best practices.
- Strong track record in developing phase-appropriate analytical methods suitable for regulatory filings, particularly for enabling (e.g., spray drying/HME) and conventional (e.g., dry/wet granulation) oral solid dosage forms.
- Solid understanding of current industry trends and regulatory expectations in analytical science areas, including stability studies, microbial control, comparability assessments, and method validation.
- Ability to travel up to 10% domestically and internationally.
ABOUT IAMBIC THERAPEUTICS
Founded in 2019 and headquartered in San Diego, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai.
MISSION & CORE VALUES
The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life Insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.