Principal Scientist - Analytical Methods Development

Who We Are

Programmable Medicine is a pre-revenue, clinical-stage biotechnology company focused on discovering and developing innovative therapies for patients with serious diseases. The company operates across multiple legal entities and partners with external CROs, CMOs, and research institutions globally. Backed by leading venture capital investors, Programmable Medicine is building a scalable technical operations function to support rapid growth and pipeline advancement.

The Position

The successful candidate will provide scientific leadership for the development, qualification, stage-appropriate validation of analytical methods supporting complex large molecule therapeutics, including antibody drug conjugates, polymer-based platforms, and other nanomedicine products. The successful candidate will partner closely with Chemistry, Translational,  Process Development, Formulation Development, Quality, Regulatory Affairs, Manufacturing, and external contract laboratories to establish robust analytical strategies that support product characterization, process understanding, product test and release, and regulatory submissions.

•  Subject matter expert in analytical methods development that uses scientific knowledge and experience to independently design, plan and execute studies in support of preclinical through Phase 2 programs

• Performs analytical development and optimizes methods in support of preclinical studies through Phase 2
• Creates and implements novel ideas and techniques to support analytical activities
• Leads analytical technology transfersto GLP laboratories in support of GMP production
• Writes analytical method development reports, SOPs, and analytical sections  of regulatory submissions
• Supervises laboratory personnel including setting priorities, monitoring work, execution of timelines, training to appropriate SOPs,  meeting quality standards, and timely completion of documentation

Job Requirements

• PhD in Analytical Chemistry or related discipline and 10+ years of relevant experience with at least 6 years of experience in the biotechnology/pharmaceutical or related industry
• Demonstrated experience supporting complex large molecule therapeutics, including at least one of the following: antibody drug conjugates, dendrimers, polymers, biologics, bioconjugates, nanoparticles, or related products.
• Extensive experience developing analytical methods supporting products from discovery through clinical development
• Thorough understanding of analytical chemistry and a well-developed understanding of  potential in-process impurities generated in production of antibody drug conjugates or polymer-drug conjugates

• Strong working knowledge of analytical techniques, including: HPLC, SEC, LC-MS/MS, LC-MS, NMR spectroscopy, UV-Vis spectroscopy, , Dynamic Light Scattering (DLS), Zeta potential analysis, 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 associated agency responses
• Demonstrated understanding of cross-functional team membership related to drug development
• Excellent project management skills with proven ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Previous experience supervising and optimizing the performance of a small scientific team
• Extensive experience in developing analytical methods using fundamental scientific principles including peer reviewed publications as co-author or lead author

About Programmable Medicine

This is a unique opportunity to join a team focused on the development of a new class of precision medicines that selectively treat diseased cells in regions of inflammation. By making precision medicine even more precise, our nanomedicine technology has the potential to change the standard of care across ophthalmology, neurology, inflammatory diseases and neuro-oncology. You will have the opportunity to learn new skills and gain a better understanding of cutting-edge technology.

We have a comprehensive compensation package including fully paid medical, dental and vision benefits for you and your family. We want our employees to become shareholders and offer new hire stock options. The company also offers participation in the annual bonus program. The salary range for MS candidates located in the Bay Area, with a minimum of 8 years of industry experience is $165,000 - $200,000, depending on years of experience and relevant skill sets.