Associate Principal Scientist, Engineering

Job Title Associate Principal Scientist, Cell Culture Sciences, Biologics Drug Substance Commercialization Location Rahway, NJ (primary) Overview Lead the strategic and technical development and commercialization of late‑stage biologic cell culture processes within our expansive Biologics S&T portfolio, driving cross‑functional partnerships, regulatory filings, and process advancement to bring lifecycle medicines to patients worldwide. Key Responsibilities Deliver robust DS strategies for successful commercialization and oversee cell culture process development, characterization, and regulatory filing activities. Provide technical oversight and leadership for all stages of cell‑culture process commercialization, including risk assessment, control strategies, and process comparability reporting. Lead regulatory activities, including drafting and reviewing IND, MAA, and BLA submissions and supporting inspections with FDA, EMA, JNDA, and TGA. Establish, manage, and mentor a multidisciplinary Cell‑Culture CMC team, aligning resources to mission priorities and fostering talent development. Drive project schedules, set clear priorities, monitor performance metrics, and deliver complex objectives on tight timelines in a rapidly changing environment. Champion cross‑functional collaboration, compliance, safety, and an inclusive culture to unify diverse teams and achieve program goals. Remove roadblocks, resolve conflicts, and escalated issues when needed, while fostering transparent communication with governance bodies. Lead business‑improvement initiatives and leverage networks to drive innovation and continuous process enhancement. Education & Experience Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with ≥8 years of relevant industry experience. Or Master’s degree in the same fields with ≥6 years of relevant industry experience. Or Ph.D. in the same fields with ≥3 years of relevant industry experience. What You Bring Proven leadership of functional teams in biologics development and commercialization. Deep expertise in cell‑culture commercialization and manufacturing operations. Strong understanding of regulatory requirements and ability to lead without authority. Ethical, resilient, and committed to excellence with strong risk‑management and strategic‑planning skills. Experience in commercial manufacturing and CMC development. Exceptional communication and stakeholder‑engagement abilities. Required Skills Adaptability, Biological Engineering, Biomanufacturing, Bioprocessing, Cell Cultures, Chemical Engineering, Cross‑Functional Collaboration, Data Analysis, Decision Making, Detail‑Oriented, Mammalian Cell Culture, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale‑Up, Mentorship, Process Improvements, Process Validation, Protein Purifications, Regulatory Submissions, Risk Analysis, Risk Assessments, Risk Control Assessment, Technical Leadership, Technical Writing, Technology Transfer. Preferred Skills Current employee or contingent worker status (optional). Benefits Competitive salary range of $142,400 - $224,100 plus annual bonus and long‑term incentive opportunities. Comprehensive benefits package including medical, dental, vision, and other insurance for employee and family. Retirement benefits including 401(k) plan with company match. Paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, 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. We provide accommodations for applicants who require them as part of the application or hiring process. #J-18808-Ljbffr