Senior Scientist, Engineering

About the role

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 ever growing and dynamic late-stage biologics pipeline within the expansive Biologics S&T portfolio.

Responsibilities

• 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.
• Support 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.
• Collaborate with colleagues across the US and internationally to elevate standards in biologics commercialization and manufacturing.
• Support Cell Culture CMC teams, and align resources to deliver on priorities.
• Mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff.
• Unite diverse teams to achieve program goals as One Team.
• Champion compliance and safety; promote a culture of diversity, inclusion, and equity.
• Work, and collaborate in internal and external cross-functional, matrixed teams.
• Remove roadblocks, resolve conflicts, and escalate issues when needed.
• Foster collaboration, ensure transparency, and engage with governance bodies.
• Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
• Lead business improvement initiatives and leverage your network to drive change.

Requirements

• 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.

Qualifications

• 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.

Skills

• Adaptability.
• Biological Engineering.
• Biomanufacturing.
• Bioreactors.
• Cell Cultures.
• cGMP Regulations.
• Chemical Engineering.
• Chromatographic Techniques.
• Clinical Judgment.
• Cross-Functional Collaboration.
• Design of Experiments (DOE).
• Detail-Oriented.
• Good Manufacturing Practices (GMP).
• Mammalian Cell Culture.
• Process Design.
• Process Optimization.
• Process Scale Up.
• Process Validation.
• Risk Analysis.
• Risk Assessments.
• Risk Control Assessment.
• Small Molecule Synthesis.
• Stakeholder Communications.
• Stakeholder Engagement.

Benefits

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Pay

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, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Schedule

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.