Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.
Overview:
The Senior Scientist, Biologics Analytical Development, supports the development of recombinant protein production processes and analytical strategies for biologic therapeutics. This role is responsible for analytical method development, product characterization, and analytical support for process development activities involving microbial and mammalian expression systems. The position contributes to the advancement of innovative therapies addressing unmet medical needs.
Key Highlights:
Analytical method development and optimization
Protein and conjugate characterization using HPLC, CE, Mass Spectrometry, and biophysical characterization techniques
Support of upstream and downstream process development
CRO/CMO oversight and technology transfer activities
GMP manufacturing support and regulatory documentation contributions
Essential Duties & Responsibilities:
Support extended characterization studies of recombinant proteins and protein conjugates using a variety of analytical techniques including LC-MS peptide mapping, U/HPLC, SEC, IEX, CE-SDS, iCIEF, GC/GC-MS, and biophysical techniques
Process and review analytical data utilizing modern chromatographic and mass spectrometry CDS/MS software platforms
Write and approve technical reports, SOPs, and method protocols.
Develop, optimize, and qualify analytical methods for biologic products.
Characterize and quantify product and process related impurities.
Support upstream and downstream process development programs.
Manage analytical activities performed by CROs and support analytical transfers to CROs and CMOs.
Review analytical data and reports supporting GMP manufacturing activities.
Author and/or review CMC sections of regulatory submissions.
Independently design, execute, and analyze laboratory experiments.
Evaluate complex scientific data and apply sound technical judgment.
Collaborate with cross-functional teams and external partners.
Author and approve technical reports, protocols, and scientific documentation.
Maintain compliance with applicable regulatory and quality requirements.
Support resource planning, equipment identification, and organizational initiatives.
Lead projects, mentor team members, and provide training as needed.
Numbers & Facts
Location
San Francisco, CA
Skills
Analysis Skillsunmatched
Analytical Developmentunmatched
Analytical Method Developmentunmatched
CMOSunmatched
Candidate Pipelineunmatched
Chromatographyunmatched
Contract Research Organization (CRO)unmatched
Cross-Functionalunmatched
GMP (Good Manufacturing Practices)unmatched
Gas Chromatography-Mass Spectrometry (GC-MS)unmatched
High Performance Liquid Chromatography (HPLC)unmatched