Job Description

Overview The Biologics Analytical Research & Development department of our company Research Laboratories Division is seeking applicants for a Principal Scientist position at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ingredients (APIs). We are looking for a team player with strong leadership skills and the passion for mentoring and collaboration in a laboratory setting. Applicants must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership, and superior written and oral communication skills. A track record of delivering impactful solutions to complex problems and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is expected. Responsibilities Lead a team of scientists and work with the group Director to define group strategy and solve complex analytical problems at the intersection of biology, chemistry, and lab informatics to enable development of biologics APIs. Mentor and develop team members; manage matrix relationships and provide coaching to peers and direct reports. Develop and execute analytical control strategies and support transfer of assays for clinical trial material and product/process development. Author and review internal technical reports, sections of regulatory filings (e.g., IND, BLA), and external scientific publications. Deliver complex objectives under aggressive timelines in a rapidly changing environment. Qualifications Education Minimum Requirements: Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of pharmaceutical industry experience, or M.S. with a minimum of 10 years, or B.S. with a minimum of 14 years of pharmaceutical industry experience. Required Experience and Skills: Extensive experience in analysis of biologics (e.g., Size Exclusion Chromatography, Ion Exchange Chromatography, Capillary Electrophoresis). 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 mentoring; experience with matrix management and peer-to-peer coaching. Demonstrated initiative, creativity, and innovation in problem solving. Background in Analytical Methodologies and understanding of Critical Quality Attributes, QbD/DOE principles, and data analysis and statistics for setting specifications. Ability to design, execute, and/or direct development and qualification of release, characterization, and stability assays for testing of clinical trial material and support of product/process development. Strong oral and written communication skills; ability to work independently on assay development and cross-functionally for successful transfer of assays; plan assay optimization and documentation to meet program deadlines. Experience authoring and reviewing internal reports, regulatory filings, and external publications. Strong ability to deliver complex objectives under aggressive timelines in a dynamic environment. Preferred Experience and Skills: Understanding of protein degradation mechanisms and link to analytical methodologies. Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as per ICH Q2 and USP. Experience with complex glycan analysis and links to mechanisms of action. Experience in analysis of various biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein). Established scientific reputation evidenced by publications and external presentations. Strong external network to benchmark competitors and equipment vendors. Experience in high-throughput experimentation and data-rich experimentation.

#AR&D

Current Employees apply here Current Contingent Workers apply here EEO and Benefits US and Puerto Rico Residents Only: Our company is committed to inclusion and provides equal opportunities to all employees and applicants. If you need an accommodation during the application or hiring process, please indicate so. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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 legally protected characteristics. We also comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement. We are proud to embrace diversity and inclusion and encourage collaboration across diverse ideas and experiences. Hybrid Work Model Effective September 5, 2023, employees in U.S. office-based positions will work a Hybrid model (three on-site days per week, with Fridays remote, days may vary by site). This model does not apply to field-based, facility-based, manufacturing-based, or fully remote roles, or roles with a collective-bargaining agreement that specifies otherwise. Salary and Benefits The salary range for this role is $153,800.00 - $242,200.00. The final salary within the range will depend on education, qualifications, experience, skills, location, and business needs. The successful candidate may be eligible for annual bonus and long-term incentives, if applicable. We offer a comprehensive benefits package, including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick time. More information about benefits is available here: Application You can apply for this role at the Merck careers site. The application deadline is stated on this posting. Important Notices San Francisco residents: we will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents: we will consider all qualified applicants in a manner consistent with state and local laws. Search firm representatives: Merck does not accept unsolicited assistance without a valid written agreement. #J-18808-Ljbffr Merck

Job Tags

Work at office, Local area, Remote work, 3 days per week,

Similar Jobs