Senior Scientist, Analytical Development

About the role

This position will serve as analytical SME to support Antibody Biologics CMC development. Develop, establish, qualify, and transfer analytical methods used to monitor the critical product quality of Antibody Biologics drug substance and drug product. Contribute to the development and implementation of analytical development strategies and workflows. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of process intermediate, drug substance, drug product at all stages of development process.

Responsibilities

• Lead analytical method development, qualification/validation and transfer for the characterization of Antibody Biologics utilizing various analytical separation techniques including but not limited to SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF
• Expand internal analytical capabilities to support method development/qualification/validation/transfer activities as well as process development activities such as cell line development, upstream/downstream development, formulation development
• Support off-site analytical method transfers, manufacturing support, and interaction with external vendors when needed
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC analytical development strategies
• Lab Personnel and ensure laboratory safety practices
• Other duties as assigned

Requirements

• BS/BA degree in chemistry or closely related field and 5+ years (7+ years preferred) of pharmaceutical industry experience, focusing on separation method development OR
• MS/MA degree in chemistry or closely related field preferred and 3+ years (5+ years preferred) of pharmaceutical industry experience noted above OR
• PhD in chemistry or closely related field (2+ years preferred) of pharmaceutical industry experience
• Expert knowledge and understanding of analytical chemistry and a thorough understanding of antibody bioprocess including cell line development, upstream development, downstream development, and formulation development
• Proficient in characterization of antibody modalities using various analytical technologies with a focus on separation technologies, including but not limited to liquid chromatography (SEC, HILIC, RP, HIC, AEX, CEX), capillary electrophoresis (Maurice, PA800+, Labchip GX/GXII, etc.), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry
• Hands on experience in homodimer/heterodimer separation method development for bi-specific/tri-specific antibodies are preferred
• Method development, qualification, validation, 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
• Excellent laboratory and productivity skills
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent problem solving and critical thinking skills

Qualifications

BS/BA degree in chemistry or closely related field and 5+ years (7+ years preferred) of pharmaceutical industry experience, focusing on separation method development OR MS/MA degree in chemistry or closely related field preferred and 3+ years (5+ years preferred) of pharmaceutical industry experience noted above OR PhD in chemistry or closely related field (2+ years preferred) of pharmaceutical industry experience

Skills

• Expert knowledge and understanding of analytical chemistry and a thorough understanding of antibody bioprocess including cell line development, upstream development, downstream development, and formulation development
• Proficient in characterization of antibody modalities using various analytical technologies with a focus on separation technologies, including but not limited to liquid chromatography (SEC, HILIC, RP, HIC, AEX, CEX), capillary electrophoresis (Maurice, PA800+, Labchip GX/GXII, etc.), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry
• Hands on experience in homodimer/heterodimer separation method development for bi-specific/tri-specific antibodies are preferred
• Method development, qualification, validation, 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

Benefits

• Annual base salary range: $110,800.00 - $151,000.00
• Annual bonus with a target of 20% of the earned base salary
• Eligibility to participate in our equity based long term incentive program
• 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 in accordance with the terms and conditions of the applicable plans