About the Role:
This position will serve as analytical development lead for multiple projects, with a focus on Biologics including monoclonal antibodies, bi-specific monoclonal antibodies, tri-specific monoclonal antibodies, and antibody conjugates. 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.

Your Contributions (include, but are not limited to):

• Lead analytical method development and validation/qualification activities for Biologics (e.g. monoclonal antibodies, bi-specific monoclonal antibodies, tri-specific monoclonal antibodies, and antibody conjugates) 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
• Deep technical expertise in separation method development (e.g. SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF etc.), potency method development (e.g. ELISA, cell-based bioassay etc.), process related impurities method development (e.g. ELISA, qPCR, LC) for Biologics and extensive knowledge of CQA assessment, analytical comparability, and stability
• 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

Requirements:

• BS/BA in Analytical Chemistry or related discipline and 15+ 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 13+ years of experience OR
• PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience
• Expert knowledge and understanding of Biologics analytical development and a thorough understanding of bioprocess as well as formulation development
• Expert knowledge of Biologics extended characterization, critical quality attribute (CQA) assessment, and structure functional relationship
• Expert knowledge of Biologics stability study
• Extensive experience and expertise with Biologics focusing on analytical method development including but not limited to release/stability method development
• Proficient in characterization of Biologics (e.g. monoclonal antibodies, antibody conjugates) 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
• Extensive knowledge of FDA, EMA, WHO, and ICH regulatory requirements and experience in IND/IMPD regulatory filing
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent project management skills

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The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.