Job DescriptionCell Culture Sciences - Biologics Drug Substance Commercialization - Pilot OperationsWe are seeking a highly motivated Scientist to play a key role in
pilot plant operations, process scale-up, and drug substance commercialization for our late-stage biologics pipeline. In this role, you will independently lead technical activities, drive process understanding, and contribute to successful technology transfers and commercial readiness efforts.
Key ResponsibilitiesPilot Operations Leadership- Independently execute and support pilot-scale mammalian cell culture campaigns, including planning, setup, operation, monitoring, sampling, data analysis, and documentation.
- Serve as a technical lead during pilot operations and provide real-time troubleshooting support.
- Ensure safe, compliant, and efficient execution of pilot manufacturing activities.
Process Scale-Up & Commercialization- Lead and support scale-up efforts from laboratory through pilot and commercial manufacturing scales.
- Evaluate process performance across scales and identify opportunities to improve robustness and manufacturability.
- Author and review technical reports supporting process transfer and commercialization activities.
Technical Development & Validation- Design, execute, and analyze process characterization studies.
- Support process performance qualification (PPQ) and continued process verification initiatives.
- Contribute scientific and technical content for regulatory filings and inspection readiness activities.
Data Analysis & Process Understanding- Analyze process data to identify trends, deviations, and opportunities for improvement.
- Apply engineering and scientific principles to establish process understanding and support control strategy development.
- Present findings and recommendations to technical teams and leadership.
Cross-Functional Collaboration- Partner closely with Process Development, Manufacturing, Quality, Validation, Supply Chain, and Regulatory Affairs organizations.
- Support technology transfer activities between development, pilot, and commercial manufacturing sites.
- Collaborate across global teams to ensure alignment on commercialization objectives.
Continuous Improvement- Identify and implement operational improvements that enhance process reliability, efficiency, and compliance.
- Support implementation of new technologies, digital tools, and advanced manufacturing practices.
- Contribute to departmental initiatives focused on operational excellence and knowledge management.
Education & Experience- Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, Biotechnology, Biochemistry, or related discipline with 3-5 years of relevant industry experience
OR- Master's degree with 1-3 years of relevant industry experience
What You BringTechnical Expertise- Experience with mammalian cell culture development and/or manufacturing.
- Knowledge of bioreactor operations and scale-up principles.
- Experience supporting pilot-scale or GMP manufacturing operations preferred.
- Understanding of biologics process development, technology transfer, and commercialization activities.
Scientific & Analytical Skills- Ability to analyze and interpret complex process data.
- Experience with statistical analysis and data visualization tools preferred.
- Strong troubleshooting and problem-solving capabilities.
Leadership & Collaboration- Ability to independently manage technical workstreams and priorities.
- Effective communication and presentation skills.
- Strong collaboration skills across scientific, engineering, and manufacturing organizations.
Personal Attributes- Strong attention to detail and commitment to data integrity.
- Growth mindset with a passion for innovation and continuous improvement.
- Demonstrated ownership, accountability, and commitment to patient-focused outcomes.
Be a Catalyst for CommercializationJoin a team where science, engineering, and manufacturing come together to bring innovative biologic medicines to patients. As a Scientist in Cell Culture Pilot Operations & Drug Substance Commercialization, you will play a critical role in scaling processes, enabling manufacturing success, and shaping the future of biopharmaceutical production. #EBRG's #VetJobs
Required Skills: Biological Manufacturing, Biological Manufacturing, Biologics, Biopharmaceutical Manufacturing, Bioproducts, Biotechnology, Biotechnology Manufacturing, Cell Culture Techniques, Chemical Engineering, Clinical Manufacturing, Commercialization, Data Analysis, Data Integrity, Detail-Oriented, Downstream Process Development, Efficiency Improvements, Experimentation, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Maintenance Supervision, Pharmaceutical Process Development, Process Analytics, Process Definition, Process Improvements, Process Scale Up {+ 9 more}
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only: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.
The salary range for this role is
$87,300.00 - $137,400.00
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.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
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.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation:Domestic/International
VISA Sponsorship:Yes
Travel Requirements:10%
Flexible Work Arrangements:Not Applicable
Shift:1st - Day
Valid Driving License:No
Hazardous Material(s):N/A
Job Posting End Date:08/30/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
