Principal Scientist, Large Molecule Analytical

Overview Principal Scientist (R5) – Large Molecule Analytical (LMA) We seek a senior scientist with strong leadership skills to define analytical strategy, lead a team and solve complex analytical problems at the interface of biology, chemistry, and laboratory informatics for the development of biologics active pharmaceutical ingredients. Responsibilities Lead a team of scientists in solving complex analytical problems and defining analytical strategy. Collaborate with the group Director and cross‑functional teams to develop and execute analytical control strategy. Mentor junior scientists and develop talent through coaching and peer‑to‑peer mentoring. Oversee the development, qualification, and transfer of release, characterization, and stability assays for clinical trial material. Author and review internal technical reports, regulatory filings, and external publications. Plan assay optimization to meet program deadlines and deliver complex objectives under aggressive timelines. Qualifications Ph.D. in analytical chemistry, biochemistry, or related field with minimum 8 years of experience in the pharmaceutical industry; M.S. with 10 years; or B.S. with 14 years. Extensive experience in biotherapeutic analysis (e.g., SEC, IEX, CE). Experience with process‑ and impurity‑related residual assay development using molecular biology and immunoassay techniques. Strong background in analytical control strategy development and execution, QbD/DOE principles, data analysis and statistics for specification setting. Demonstrated ability to develop talent through mentoring skills. Experience in matrix management and peer‑to‑peer coaching. Excellent written and oral communication skills. Strong team‑player with ability to work independently and cross‑functionally. Preferred Experience and Skills Understanding of protein degradation mechanisms and linkage to analytical methodologies. Experience with qualification, validation, and transfer of assays to GxP or regulated laboratories (ICH Q2, USP). Experience with complex glycan analysis and biological modalities such as mAb, ADC, fusion protein. Knowledge of antibody‑drug conjugate method development. Experience with high‑throughput experimentation and data‑rich experimentation. Strong external network for benchmarking competitors and equipment vendors. Job Details Location: Rahway, New Jersey Employment type: Regular (Full‑time) Relocation: Domestic Travel: 10% VISA sponsorship required: Yes Salary Range $156,900.00 – $247,000.00 Benefits Medical, dental, vision, and other health insurance (employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. Benefits details are available at EEO Statement We 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC. #J-18808-Ljbffr MSD Malaysia