USA - Pennsylvania - West Point, United States of America
Onsite
Job Description
We are seeking a motivated and experienced scientist to join the Vaccine BioAssay group in West Point, PA. The position is within Global Quality Large Molecule Analytical Sciences (GQ-LMAS) and provides technical support for analytical methodologies used in testing of commercial large molecule products.
Large Molecules Analytical Sciences, within the Manufacturing Division is responsible for the commercialization of vaccine analytical techniques from Phase III through launch including transfer to commercial manufacturing sites as well as in-line analytical support to enable world-wide robust vaccine availability. This team is highly motivated, fast-paced and focused on the rapid advancement of our company's late-stage pipeline, plus growth of existing products.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Key Functions:
Serve as a subject matter expert in vaccine bioassays, providing support and training for LMAS and QC laboratories globally.
Contribute to QC investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
Contribute to the Assay Procedure Lifecycle Management for vaccine ELISAs and similar assays across the large molecule portfolio including method optimization and modernization, assay performance monitoring, and optimization of workflows.
Provide authorship or review of analytical procedures, methods transfer protocols and reports, technical reports, experimental designs and regulatory submission documents.
Provide technical input during inspections and audits.
Support the development of digital methods and deploying to global QC sites
Minimum Education Requirement and Experience:
Bachelor’s Degree (BA/BS) with a concentration in sciences with eight (8) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR
Master’s Degree (MA/MS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR
PhD with a concentration in sciences with three (3) years of experience working in the field of analytical testing, development, transfer, and/or validation.
Required:
Experience and expertise with bioassays, specifically ELISA immunoassays or other binding-based assay technologies for large molecules.
Experience in a current Good Manufacturing Practices (cGMP) laboratory environment in the area of large molecules (vaccines, biologics) with experience in immunochemical analytical methods.
Development and management of project timelines and deliverables.
Authoring and review of technical documents
Ability to work independently and within a cross-functional team
Good technical, communication (oral and written), interpersonal, and teamwork skills
Strong organizational and project management skills.
Ability to effectively identify and communicate risks.
Experience with drug substance and drug product release, stability and extended characterization testing for vaccines and biologics.
Preferred:
Experience with late-stage method development, validation, transfer, and troubleshooting.
Digital competency creating digital methods and templates, including SoftMax Pro.
Experience with Quality and Regulatory Requirements
Working knowledge of CMC filing requirements
Working experience with CMOs and CROs
Required Skills:
Adaptability, Analytical Method Development, Analytical Testing, Assay Development, Biochemical Assays, Biological Assay Development, Cell-Based Assays, Communication, Cross-Functional Teamwork, Deviation Management, ELISA Techniques, Enzyme Linked Immunosorbent Assay (ELISA), External Collaboration, Good Manufacturing Practices (GMP), Immunoassays, Process Analytical Technology (PAT), Project Management, Protein Analysis, Sandwich ELISA, Teamwork, Working IndependentlyPreferred Skills:
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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:
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.
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The salary range for this role is
$142,400.00 - $224,100.00This 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
07/10/2026*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.
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