Associate Scientist Engineering - Biologics Process Development and Commercialization

MSD Malaysia; Northern (KY); Hybrid; USD 72,000 - 113,000; Full time

Job summary

Merck & Co., Inc. is seeking an Associate Scientist to lead Biologics Process Analytics Commercialization. You will guide non-GMP testing, establish new analytical assays, and manage a small team while ensuring data integrity and timely results.

You will collaborate with internal partners, maintain ALCOA-compliant documentation, and drive continuous improvement in analytical operations in a fast-paced biologics environment.

Qualifications

• BS degree in a relevant analytical science field or chemistry.
• Experience with HPLC/UPLC and protein analytics techniques.
• Strong data analysis skills and ability to work independently.

Responsibilities

• Lead day-to-day scoping and prioritization for testing non-GMP samples.
• Lead establishment of new assays and molecules for the team.
• Oversee lab operations, scheduling, training, and inventory management.
• Ensure safety, compliance, and ALCOA documentation across activities.

Skills

HPLC/UPLC

Capillary electrophoresis

Data analysis

Analytical method development

Power BI / Spotfire

Laboratory leadership

Documentation (ALCOA)

Lab operations

Problem solving

Education

B.S in Analytical Sciences / Chemistry / Chemical Engineering / Biochemistry

Tools

Empower

Job description

**Associate Scientist, Process Analytics Lab Lead, Biologics Drug Substance Commercialization** **Join Our Team as a Biologics Process Analytics Associate Scientist!**We are seeking a strategic and technical scientist with expertise in process analytics 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 an Associate Scientist in Biologics Process Analytics Commercialization, you’ll be at the forefront of supporting a rich robust pipeline by delivering analytic insights to process stakeholders.As the laboratory lead, you will troubleshoot and solve problems for the laboratory and operating systems, applying technical skills to bring in new assays in our non-GMP laboratory. In addition, you will lead a small team with the goals of maintaining a high performing team, with focuses on data integrity, quality and meeting desired turnaround times. You will also work with internal and external partners to provide reliable and efficient laboratory operations. 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:** * **Team Leadership**: Lead the day-to-day scoping and prioritization for testing of non-GMP analytical samples, for a team of non-Company employees. Appropriately communicate and delegate to team members to ensure program deliverables are met and resource allocations are managed appropriately* **Lab Operations Leadership:** Working closely with lead of non-Company employees, the lab lead will oversee daily lab operations, lab tier, lab preparation, scheduling, training, inventory management, and operational metrics to enable efficient experimental execution and continuous improvement. Lead establishment of new assays and new molecules for the team.* **Reliability and Capability Improvement:** Resolve equipment and system issues, reduce downtime and excessive maintenance or energy use, and partner with vendors and internal stakeholders to enable capability enhancements.* **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.* **Cross-Functional Collaboration:** Unite diverse teams to achieve program goals as One Team. Collaborate with counterpart in NJ to ensure alignment across teams. 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.* **Documentation:** Maintain high-quality documentation practices compliant with ALCOA principles. Author and/or review technical documents including development reports, analytical test protocols, laboratory procedures, comparability protocols, etc.* **Communication:**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. **Education Guideline:** * B.S in Analytical Sciences/ Chemistry/ Chemical Engineering/ Biochemistry or related field **Preferred Skills**:· * Experience with HPLC/UPLC/capillary electrophoresis executions and data analysis of therapeutic proteins using various techniques such as IEX, SEC, HIC.* Experience with Empower software.* Leadership skills and ability to manage the daily tasks of a small team of analysts.* Ability to perform benchtop laboratory operations.* Demonstrated ability to plan, execute, optimize, and troubleshoot analytical assays.* Outstanding communication (oral and written), organization and time management skills; ability to work independently and collaboratively.* Motivation to learn new skills, willingness to take on new challenges, and scientific curiosity.* Experience in using Power BI, Spotfire, or other data analytical software.* Ability to work independently and as part of a team, self-motivator, positive attitude, and proactive problem solver.* Ability to foster a collaborative working environment.* Adaptability and capability to respond to changing needs.* Strong attention to detail and quick learner.* Demonstrate ability and/or aptitude in data processing and advanced data analysis.* Some knowledge and understanding of pharmaceutical drug substance processing.**Required Skills:**Ability to Coordinate, Ability to Coordinate, Adaptability, Chemical Engineering, Chemistry, Data Analysis, Data Analysis Tools, Experimentation, Gel Electrophoresis, Laboratory Management, Laboratory Operations, Laboratory Research, Laboratory Safety, Laboratory Techniques, Maintenance Supervision, Organizing, Pharmaceutical Sciences, Proactive Thinking, Process Design, Process Improvements, Product Formulation, Proper Documentation, Protein Purifications, Recordkeeping, Situational Leadership {+ 6 more}**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$71,900.00 - $113,200.00This 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:**No**Travel Requirements:**10%**Flexible Work Arrangements:**Not Applicable**Shift:**1st - Day**Valid Driving License:**No**Hazardous Material(s):**Yes**Job Posting End Date:**10/6/2026**\\*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.