Principal Scientist - Analytical Development (ADCs)

Programmable Medicine Operatin•Redwood City, CA

3h•$165,000 - $200,000

About The Position

The Principal Scientist will provide scientific leadership for the development, qualification, and stage-appropriate validation of analytical methods supporting 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 position serves as a subject matter expert, independently designing, planning, and executing analytical studies for preclinical through Phase 2 programs. Responsibilities include developing and optimizing methods, creating new approaches, leading transfers to GLP laboratories in support of GMP production, preparing method-development reports, SOPs, and regulatory-submission analytical sections, and supervising laboratory personnel. The company describes this as an opportunity to contribute to precision nanomedicines intended to treat diseased cells in regions of inflammation and to gain experience with cutting-edge technology.

Requirements

PhD in Analytical Chemistry or a related discipline.
10+ years of relevant experience, including at least 6 years in the biotechnology, pharmaceutical, or 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, and experience supporting regulatory submissions, including IND, NDA, and agency responses.
Demonstrated understanding of cross-functional team membership in drug development.
Excellent project-management skills, with a 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 functions 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 supporting preclinical studies through Phase 2.
Create and implement novel ideas and techniques for 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, training staff on SOPs, ensuring quality standards, and completing documentation on time.