Job DescriptionThe Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company's lifesaving vaccines in bulk and finished forms.
The Process Support Lab at the Durham site is seeking a Specialist with strong technical, interpersonal, communication, and collaboration skills. The PSL Specialist will be responsible for managing key projects related to Vaccines Manufacturing support, including laboratory study execution, project planning, data analysis, technical documentation, and cross-functional coordination. This role will support manufacturing investigations, process monitoring, technical transfer activities, and continuous improvement efforts for Durham vaccine products and pipeline programs. The successful candidate will be a hands-on technical contributor with familiarity in laboratory analytical equipment, cell culture processing, aseptic practices, and cGMP documentation expectations. To be successful in this role, the candidate must be able to manage multiple priorities in a fast-paced environment while partnering effectively with Manufacturing, Quality, Technical Operations, and laboratory teams.
The candidate will be required to work in a fast-paced environment. Off-shift or weekend coverage will occasionally be needed to assist the technical team, based on project-specific assignments and/or the vaccine production schedule.
Primary Duties:- Manage key PSL projects related to Vaccines Manufacturing support, including project scope, planning, execution, documentation, and stakeholder communication.
- Serve as a technical contributor for laboratory studies supporting manufacturing investigations, process monitoring, technical transfer, and process improvement activities.
- Author and review experimental design proposals, laboratory protocols, technical reports, data summaries, and project updates in alignment with cGMP expectations.
- Apply technical understanding of vaccine manufacturing processes, including upstream processing, cell culture operations, downstream processing, drug product support, and laboratory analytics.
- Operate, coordinate, or support laboratory analytical equipment used for in-process, post-process, and investigational sample testing, including method execution, troubleshooting, and equipment readiness activities.
- Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products.
- Support cell culture processing activities, including preparation, execution, monitoring, sampling, data review, and troubleshooting in laboratory or manufacturing-support settings.
- Actively participate on cross-functional teams to advance project goals and deliverables related to vaccine processes or analytics.
- Provide SME knowledge for manufacturing investigations (Product, process, and testing deviations)
Required Education, Experience and Skills:- Bachelor's degree in Engineering or Science AND a minimum of two (2) years of relevant experience OR Master's degree in Engineering or Science OR Ph.D. with relevant academic experience
- Experience in vaccine or biologics processing, including either lab- or manufacturing- scale support in analytics.
- Experience authoring technical documentation within a cGMP context
- Proven technical communication (written & presentation) skills.
- Strategic plan development and management
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
Preferred Experience and Skills- Vaccine or biologics manufacturing within an aseptic, cGMP environment
- cGMP manufacturing or Quality Operations support including providing immediate responses on the shop floor to deviations and potential deviations
- Ability to drive studies and experiments in the context of a long-term commercialization plan
- Design of Experiment (DOE) and One Factor at a Time (OFAT) experimental design
- Experience authoring technical documents supporting regulatory filings (IND, BLA).
- Experience using digital visualization tools (PowerBI, JMP, etc.)
- Ability to provide scientific mentorship and guidance to technical colleagues
- Prior experience performing analytical assays (i.e. potency assays, serial dilutions, moisture testing, SDS-Page, dry weight, UV-Vis, BCA Assay)
- Prior experience with any of the following equipment ex: SoloVPE, Lighthouse, Cedex Bio, ViCell, UPLC, plate readers etc.
Required Skills: Adaptability, Adaptability, Analytical Instrumentation, Aseptic Handling, Biologics, Culture Media, Data Analysis, Design of Experiments (DOE), Downstream Processing, Equipment Troubleshooting, Experimental Methods, Good Manufacturing Practices (GMP), Laboratory Instrumentation, Lean Manufacturing, Perform Testing, Personal Initiative, Process Optimization, Process Testing, Professional Integrity, Project Management, Regulatory Submissions, Root Cause Analysis (RCA), Sample Testing, Scientific Research, Technical Presentations {+ 5 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.
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:No relocation
VISA Sponsorship:No
Travel Requirements:10%
Flexible Work Arrangements:Not Applicable
Shift:1st - Day
Valid Driving License:No
Hazardous Material(s):N/A
Job Posting End Date:10/1/2026
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