Principal Scientist - Analytical Methods Development
About 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.
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
- History of publications or presentations related to analytical methods development
- Intellectually curious, enjoys scientific challenges and solving unique problems
- 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
Responsibilities
- 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
Benefits
- fully paid medical, dental and vision benefits for you and your family
- new hire stock options
- participation in the annual bonus program
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
