Principal Scientist, Analytical Development
About The Position
This position will serve as analytical development lead for multiple projects, with a focus on monoclonal antibodies including complex modalities such as bi-specific, tri-specific, and fusion proteins. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify analytical methods used to control in process intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.
Requirements
- BS/BA in Analytical Chemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR MS/MA in Analytical Chemistry or related discipline and 10+ years of experience OR PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience
- Expert knowledge and understanding of analytical chemistry, separation sciences, and a thorough understanding of bioprocess as well as formulation development
- Extensive experience and expertise with monoclonal antibody modalities focusing on analytical method development including release/stability method development
- Excellent interpersonal skills with strong oral and written communication abilities
- Excellent laboratory and productivity skills
- Proficient in characterization of monoclonal antibody modalities using various modern technologies. They may include but not limited to size exclusion liquid chromatography, reverse phase liquid chromatography, hydrophilic interaction liquid chromatography, ion exchange liquid chromatography, hydrophobic interaction liquid chromatography, mixed mode liquid chromatography, UPLC/HPLC, capillary electrophoresis (Maurice/PA800+), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry, ELISA, bioassays, and molecular analysis
- Method development, validation, qualification, and transfer experience in Analytical Development
- Comprehensive understanding of cGMP requirements in drug substance and drug product
- Expert knowledge of cross-functional understanding related to drug development
- Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
Responsibilities
- Lead analytical method development and validation/qualification activities for monoclonal antibodies within cGMP compliance in support of preclinical through commercialization
- Represent Analytical development on cross-functional teams.
- Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
- Direct laboratory work and/or lab personnel within the company and at external vendors
- Technical expertise in separation techniques (e.g. SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF etc.) for monoclonal antibodies
- Support off-site analytical method transfers, manufacturing support, and interaction with external vendors
- Provide input into CMC regulatory documentation and supporting work
- Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC strategies
- Contribute to development of policies and department strategies
- Build and enhance internal and external professional relationships
- Support career development and technical growth of team members
- Present finding at varying levels across the company
- Other duties as assigned
Benefits
- retirement savings plan (with company match)
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Principal
