Senior Specialist, Process Support Lab

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

The Maurice R. Hilleman Center for Vaccine Manufacturing, located in Durham, NC, is a state-of-the-art facility established in 2004 that manufactures our Company's lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company's Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years, as well as future anticipated growth as part of the new product vaccine tech transfers to the facility.

The Process Support Lab at the Durham site is seeking a Senior Specialist with outstanding interpersonal, communication, and collaboration skills.  The PSL Senior Specialist will be responsible for participating in lab execution as well as leading a team of scientists and engineers that are study leads for analytical projects. The candidate must have demonstrated people management skills, as well as ability to support and mentor others on data analysis, technical writing, and lab execution / operations.  The Senior Specialist will be responsible for leading and/or supporting their team to lead various experiments in lab-scale vaccine process development, technical transfer support, and post commercial process enhancements activities for multiple pipeline vaccine programs as needed based on our dynamic project portfolio. To be successful in this role, you will need to be an energetic, technical contributor with strong social, communication, partnership, and leadership skills.

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. 

Responsibilities

• Manage PSL study leads on the team, specifically analytics team.
• Serve as a team Subject Matter Expert (SME) in technical data analysis. Leverage these skills to serve as a mentor in up-skilling and supporting peers in statistical tool and graphing techniques for experimental design, analysis, and process monitoring of manufacturing and Quality Operations testing, as needed.
• Provide technical review and/or approval of PSL team experimental design proposals, analysis, technical protocols and reports.
• Leverage various technical background (upstream, downstream, drug product, analytical) to lead and support late-stage process development, scale-down model development/execution/implementation, process characterization, commercial technology transfer, and qualification studies.
• Support workstreams associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and drug product.
• Execute bio-analytical assays for in-process and post-process samples, and support assay qualifications or trouble-shooting of in-process assays in the tech transfer and manufacturing spaces.
• Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products.
• Assist in design and execution of lab experiments to support process characterization, commercial technology transfer, and qualification studies associated with the development and implementation of bulk processes, systems and facilities related to pipeline vaccine bulk products.
• Actively participate on cross-functional teams to advance project goals and deliverables related to vaccine processes or analytics.
• Lead technical, operational, and business system improvement projects.
• Provide SME knowledge for manufacturing investigations (Product, process, and testing deviations).

Qualifications

Required

• Bachelor's degree in Engineering, Science or related discipline with a minimum of five (5) years of required experience in vaccine or biologics manufacturing within an aseptic, cGMP environment, OR Master's degree with a minimum of three (3) years of required experience OR Ph.D. with relevant academic experience.
• Proven leader with demonstrated people management experience.
• 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.
• Proficient using statistical tools (JMP or Minitab) for experimental design, data analysis and control chart trending.
• 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

• 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.

Required Skills:

Adaptability, Adaptability, Assay, Biochemical Assays, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Change Control Processes, Customer-Oriented, Deviation Management, Engineering Standards, Fast-Paced Environments, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Process Validation, Mentor Coaching, Mentorship, People Management, Pharmaceutical Biology, Plan of Action and Milestones (POA&M), Process Characterization, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Management {+ 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.

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 Rights

EEOC GINA Supplement​

We 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 Acts

The salary range for this role is

$117,000.00 - $184,200.00

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/5/2026

*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.