Senior Scientist, Engineering- Lab Start-Up and Commercialization

MSD Malaysia; Northern (KY); Hybrid; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. in the US seeks a Senior Scientist to lead Biologics Conjugation Commercialization, starting up lab capabilities and establishing scale-down models across the portfolio.

The role oversees lab operations, asset management, safety compliance, and cross-functional work to deliver PPQ, regulatory filings, and process improvements in a highly collaborative, hybrid work environment.

Qualifications

• Experience leading lab start-up and operations.
• Knowledge of conjugation chemistry techniques.
• Experience with potent compounds and high-containment labs.
• Experience with capital projects and project management.
• Experience with regulatory submissions and process validation.

Responsibilities

• Lead daily lab operations and scale-down models.
• Drive capital asset startup, maintenance, and calibration.
• Ensure safety, compliance, and Process Safety Management.
• Collaborate with cross-functional teams to meet program goals.
• Develop and implement lab scale-down models for PPQ and filings.

Skills

Conjugation Chemistry

ADC

Capital Planning

DOE

Process Scale Up

Project Management

GMP/cGMP

Lab Operations

Risk Management

Education

Bachelor's degree in Chemical Engineering

Master's degree in Chemical Engineering

PhD in Chemical Engineering

Tools

SAP

Procal

Maximo

QlikSense

Spotfire

Job description

**Job Description****Join Our Team as a Biologics Conjugation Senior Scientist!**We are seeking a strategic and technical scientist with expertise in laboratory start up and operations ideally in a development & commercialization space to support our ever growing and dynamic late-stage biologics pipeline within the expansive Biologics S&T portfolio.**Why You'll Love This Role:**As a Sr. Scientist in Biologics Conjugation Commercialization, you’ll be at the forefront of starting up new lab capabilities for conjugation. Setting up systems and processes to help the lab operate efficiently and effectively.As the laboratory manager, you will troubleshoot and solve problems for the laboratory and operating systems, and help drive capital planning processes and asset management programs. A key deliverable of our commercialization team is to have qualified scale down models for our conjugation processes, and you will be instrumental in design and establishment of those models to support process characterization, right first time PPQ and regulatory filings. You will engage our program team members to understand their needs and continually look to improve operations by developing efficient solutions that will support business objectives and ensure continuity and Safety, and Environmental compliance.**Key Responsibilities:*** **Scientific Engagement:** Help the Biologics Conjugation Commercialization team with scientific direction and consistent establishment of lab scale down models to be used across our portfolio.* **Lab Operations Leadership:** Lead daily lab operations, including scheduling, training, inventory management, tiers and operational metrics to enable efficient experimental execution and continuous improvement.* **Asset Reliability and Capability Leadership:** Lead capital asset startup, equipment ownership, project planning, maintenance, calibration, troubleshooting, and root cause failure analysis to ensure laboratory equipment and systems remain reliable, accurate, efficient, and ready for use.* **Compliance, Safety, and Process Safety Leadership:** Ensure laboratory activities, systems, and equipment are maintained in compliance with safety, environmental, quality, regulatory, and Process Safety Management requirements, including appropriate controls for work involving potent compounds.* **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. Experience and aptitude to work, and collaborate in internal and external cross-functional, matrixed teams.* **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.**What You Bring:*** 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* Exceptional communication and stakeholder engagement skills* Sound judgment and issue-resolution mindset,* Ability to navigate ambiguity, remove barriers, and escalate appropriately to keep work moving.**Preferred Skills**:* Laboratory start-up experience* In-depth knowledge of conjugation chemistry techniques.* Experience working in laboratories that handle potent compounds, high-containment materials, or specialized safety controls.* Experience in pilot or commercial scale manufacturing of biological molecules.* Familiarity with late-stage process development, process characterization, scale down model qualification, process validation regulatory submissions, and working with external contract organizations.* Minimum of 3 years experience troubleshooting equipment and utility systems* Minimum of 3 years experience executing/supporting Capital projects/Project Management* Understanding of or experience with Capital and Profit Planning Processe* Experience with Computerized Maintenance Management System (CMMS) software such as SAP, Procal, or Maximo* Experience in using QlikSense, Spotfire, or other data analytical software* Experience in performing root cause analysis**Required Skills:**Antibody Drug Conjugates (ADC), Bioconjugation, Bioreactors, Capital Planning, Capital Project Management, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Conjugation Chemistry, Design of Experiments (DOE), Detail-Oriented, Good Manufacturing Practices (GMP), Influencing Without Authority, Laboratory Operations, Laboratory Setup, Leadership, Process Design, Process Optimization, Process Scale Up, Project Development, Project Management, Project Resource Management, Root Cause Investigations, Technology Transfer**Preferred Skills:**Current Employees apply HERECurrent 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.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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA SupplementWe are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$117,000.00 - $184,200.00This 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**VISA Sponsorship:**Yes**Travel Requirements:**25%**Flexible Work Arrangements:**Hybrid**Shift:**1st - Day**Valid Driving License:**No**Hazardous Material(s):**n/a**Job Posting End Date:**09/30/2026**\\*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.**Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.