Job DescriptionAssociate Scientist, Process Analytics Lab Lead, Biologics Drug Substance CommercializationJoin 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.
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:
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- 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 HERE
Current Contingent Workers apply HERE
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:10/7/2026
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