Senior Scientist, Engineering

Overview Join Our Team as a Biologics Cell Culture Senior Scientist! Are you ready to take your career to the next level? We are seeking a strategic and technical scientist with expertise in cell culture development & commercialization to spearhead our late-stage biologics pipeline within the Biologics S&T portfolio. Why You\'ll Love This Role: As a Sr. Scientist in Biologics Cell Culture Commercialization, you\'ll be at the forefront of scientific advancement, providing strategic and tactical technical direction through cross-functional partnerships with key business units and customers. Your participation will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing sites, process validation, second generation process development and health authority licensure. You\'ll be supporting the charge in transforming our late-stage pipeline into reality bringing lifesaving medicines to our patients worldwide. Global Impact Collaborate with colleagues across the US and internationally to elevate standards in biologics commercialization and manufacturing. Your work will shape the future of biologics on a global scale. Responsibilities Technical Strategy: Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline. Technical knowledge: Fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Independent planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process - comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA). Leadership: Support Cell Culture CMC teams, align resources to deliver on priorities, and mentor a team of scientists specializing in biologics commercialization. Action-oriented mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve. Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Work with internal and external cross-functional, matrixed teams. Problem Solving: Remove roadblocks, resolve conflicts, and escalate issues when needed. Communication: Foster collaboration, ensure transparency, and engage with governance bodies. Excellent interpersonal and communication skills. Project Management: Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment. Recognition: Celebrate team achievements and foster a culture of appreciation. Innovation: Lead business improvement initiatives and leverage your network to drive change. Education & Experience Bachelor\'s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience. OR Master\'s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experience. OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a no minimum relevant knowledge. Required Experience and Skills Expertise in cell culture commercialization and manufacturing operations Understanding of regulatory requirements Ability to lead without authority, build trust, and inspire accountability Ethical, resilient, and committed to excellence Skilled in risk management, team facilitation, and strategic planning Experience in commercial manufacturing and CMC development Exceptional communication and stakeholder engagement skills Salary, Benefits & Additional Information The salary range for this role is $117,000.00 - $184,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee\'s position within the salary range will be based on several factors including education, qualifications, experience, and location. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at Equal Opportunity & Accessibility We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants. We comply with applicable laws and regulations and provide accommodations in the hiring process when requested. For more information about personal rights under U.S. EEO laws, visit EEOC Know Your Rights and related resources. Application & Contacts You can apply for this role through The application deadline is stated on this posting. #J-18808-Ljbffr Merck & Co.