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Merck

Principal Scientist, Biologics Analytical R&D

Merck, Rahway, New Jersey, us, 07065

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Principal Scientist, Biologics Analytical R&D

The Biologics Analytical Research & Development department is seeking a Principal Scientist to work closely with the group Director to define group strategy and lead a team of scientists in solving complex analytical problems. The ideal candidate will have strong leadership skills, excellent scientific leadership, and superior communications skills. A track record of delivering impactful solutions to complex problems and evidence of strong cross-functional collaboration is expected. Job Description

The Principal Scientist will work on the development of biologics active pharmaceutical ingredients (APIs) and will be responsible for leading a team of scientists, defining group strategy, and collaborating with other departments. Responsibilities

Lead a team of scientists in solving complex analytical problems Define group strategy and collaborate with other departments Develop and execute analytical control strategies Mentor and develop talent through good mentoring skills Take initiative, be creative, and innovate in problem-solving Qualifications

Education Minimum Requirements: Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 10 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry/biochemistry or related field with a minimum of 14 years of experience in the pharmaceutical industry. Extensive experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques Strong background in analytical control strategy development and execution Demonstrated ability to develop talent through good mentoring skills Demonstrated ability for taking initiative, creativity, and innovation in problem solving Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development A strong team player with excellent oral and written communication skills Preferred Experience And Skills

Understanding of protein degradation mechanisms and link between analytical methodologies for analysis Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment Experience with complex glycan analysis and link to mechanisms of actions Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein) Established scientific reputation supported by publications and external presentations Strong external network to benchmark competitors and equipment vendors Experience in high-throughput experimentation and data-rich experimentation We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

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