Associate Principal Scientist - Biology-Discovery

Merck & Co. • Elkhorn, NE

217d • $139,600 - $219,700 • Onsite

About The Position

We are seeking a highly skilled Scientist with advanced expertise in analytical assay development and optimization for the physicochemical characterization of monoclonal antibodies. The Individual will work as part of a rapidly growing team focusing on lead selection for new projects and development of leads from established discovery pipeline. The ideal candidate will have a strong background in protein characterization techniques, solid understanding of developability assessment for monoclonal antibodies and experience working with Contract Development and Manufacturing Organizations (CDMOs). This role will be critical in supporting our therapeutic monoclonal antibody development programs.

Requirements

• Ph.D. in Biochemistry, Molecular Biology or a related discipline
• A minimum of 5 years of experience in analytical characterization of antibody therapeutics
• Proficiency in various protein characterization techniques (SEC, IEX, CE, HIC, cIEF, CE-SDS)
• Deep understanding of biophysical properties of proteins and their implications for therapeutic development
• Experience with antibody developability assessment methodologies and tools
• Familiarity with regulatory requirements for biologics
• Proven ability to work effectively in a team-based environment
• Excellent problem-solving skills and attention to detail
• Strong communication skills, both written and verbal
• Ability to meet deadlines in a fast-paced environment
• Ability to manage two or more projects simultaneously

Nice To Haves

• 8-10 years of experience working in a field relevant to discovery or development of antibody therapeutics
• Creativity and a proven track record
• Strong background in R&D of antibody or other biologics with experience in their identification and selection
• Strong knowledge in antibody structure-function relationship is an asset
• Experiences with the characterization of antibodies across a variety of therapeutic areas
• Knowledge of ICH guidelines and regulatory submission requirements is a plus
• Experience in collaboration with external partners, including CDMOs is a plus

Responsibilities

• Design, develop, and optimize analytical assays for the physicochemical characterization of monoclonal antibodies, including but not limited to Size exclusion chromatography (SEC), Ion exchange chromatography (IEX), Hydrophobic Interaction Chromatography (HIC), cIEF, Reverse Phase HPLC (RP-HPLC) and Capillary electrophoresis (CE)
• Conduct experiments to support developability assessments of monoclonal antibodies to evaluate their suitability for therapeutic use, including assessment of solubility, aggregation propensity, and formulation compatibility
• Conduct comprehensive characterization studies to assess the purity and stability of monoclonal antibodies
• Ensure all analytical methods comply with industry best practices
• Work closely with CDMOs to transfer analytical methods, troubleshoot issues, and ensure timely delivery of results
• Analyze experimental data, prepare technical reports, and present findings to cross-functional teams and stakeholders
• Identify opportunities for process improvements and implement best practices in assay development and validation
• Provide guidance and mentorship to junior scientists and laboratory staff
• Develop and manage project specific milestones and timelines
• Manage the R&D relationships with external service providers
• Prepare progress reports and make presentations to stakeholders
• Stay informed of external advances & technologies to enhance the product development portfolio
• Communicate progress and plans to a variety of stakeholders with diverse expertise
• Provide support, coaching or assistance to other team members

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree