Principal Scientist (Formulations)

Programmable Medicine Operatin•Redwood City, CA

4d•$165,000 - $200,000

About The Position

Programmable Medicine is seeking a Principal Scientist to provide scientific leadership for developing, qualifying, and stage-appropriately validating analytical methods for complex large-molecule therapeutics, including antibody drug conjugates, polymer-based platforms, and other nanomedicine products. The role partners with Chemistry, Translational, Process Development, Formulation Development, Quality, Regulatory Affairs, Manufacturing, and external contract laboratories to establish analytical strategies for product characterization, process understanding, product testing and release, and regulatory submissions. The successful candidate will serve as a subject matter expert in analytical method development, independently designing, planning, and executing studies supporting preclinical through Phase 2 programs. The role also leads analytical technology transfers to GLP laboratories in support of GMP production, prepares method-development reports, SOPs, and analytical sections of regulatory submissions, and supervises laboratory personnel. This is an opportunity to join a clinical-stage biotechnology company developing precision nanomedicines for serious diseases. The position offers a comprehensive compensation package, fully paid medical, dental, and vision benefits for employees and their families, new-hire stock options, and participation in an annual bonus program. The stated salary range for PhD candidates in the Bay Area with at least 10 years of industry experience is $165,000–$200,000, depending on experience and relevant skills.

Requirements

PhD in Analytical Chemistry or a related discipline.
At least 10 years of relevant experience, including at least 6 years in the biotechnology, pharmaceutical, or a related industry.
History of publications or presentations related to analytical method development.
Demonstrated experience supporting complex large-molecule therapeutics, including at least one of ADCs, dendrimers, polymers, biologics, bioconjugates, nanoparticles, or related products.
Extensive experience developing analytical methods for products from discovery through clinical development.
Thorough understanding of analytical chemistry and potential in-process impurities generated in production of antibody drug conjugates or polymer-drug conjugates.
Strong working knowledge of HPLC, SEC, LC-MS/MS, LC-MS, NMR spectroscopy, UV-Vis spectroscopy, dynamic light scattering (DLS), zeta potential analysis, and multi-angle light scattering (MALS).
Experience leading analytical method transfers to GMP manufacturing sites and familiarity with CDMO and CRO management.
Strong knowledge of FDA, ICH, USP, EMA, and global CMC regulatory requirements, with experience supporting regulatory submissions, including IND and NDA submissions and agency responses.
Demonstrated understanding of cross-functional team membership in drug development.
Excellent project management skills and proven ability to meet multiple deadlines across projects and programs accurately and efficiently.
Previous experience supervising and optimizing the performance of a small scientific team.
Extensive experience developing analytical methods using fundamental scientific principles, including peer-reviewed publications as a co-author or lead author.
Intellectual curiosity, enjoyment of scientific challenges, and ability to solve unique problems.

Responsibilities

Provide scientific leadership for development, qualification, and stage-appropriate validation of analytical methods for complex large-molecule therapeutics.
Partner with internal cross-functional groups and external contract laboratories to establish analytical strategies for characterization, process understanding, product testing and release, and regulatory submissions.
Independently design, plan, and execute analytical studies supporting preclinical through Phase 2 programs.
Perform analytical development and optimize methods for preclinical through Phase 2 studies.
Create and implement novel ideas and techniques to support analytical activities.
Lead analytical technology transfers to GLP laboratories in support of GMP production.
Write analytical method-development reports, SOPs, and analytical sections of regulatory submissions.
Supervise laboratory personnel by setting priorities, monitoring work and timelines, providing SOP training, ensuring quality standards, and supporting timely documentation.