Scientist, GQLMAS Vaccines ELISA

Job Description

Scientist (R2), GQLMAS Vaccines ELISA

Job Description:

Global Quality Large Molecule Analytical Sciences, in our Manufacturing Division, provides global analytical support for our Company's in-line products to enable world-wide robust product availability. Our Manufacturing & Supply Division is committed to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners create an interdependent global manufacturing network that is committed to delivering high quality, reliable supplies to customers and patients on time, every time.

Position Description:

We are seeking a highly motivated individual to join our team as a Scientist in our Bioassay Vaccine group supporting our in-line vaccine programs. This position will work in a Good Manufacturing Principle (GMP) environment under the direction of a laboratory lead and will be expected to execute bioassays for vaccines such as immunoassays (i.e. ELISA) and enzyme activity assays and contribute to maintenance of cGMP compliant labs. The candidate will work with colleagues to deliver high quality results for these assays by supporting assay execution, transfer, technical troubleshooting, and life-cycle management of methods supporting our company's in-line vaccines.

Specific Job Responsibilities Include :

• Analytical ELISA and enzyme activity method execution and analysis
• Documentation of laboratory execution applying Good Documentation Practice (GDP) principles.
• Management of individual project deliverables as they fit into the larger overreaching project timelines
• Driving deviation incidents and investigations through data gathering, hypothesis testing or other technical troubleshooting, as well as CAPA creation and implementation
• Authoring of technical documents, including protocols and reports
• Technical troubleshooting and identifying continuous improvement opportunities
• Routine laboratory management tasks including those related to equipment maintenance, safety and GMP compliance
• Ability to work independently and within cross-functional project teams
• Commercial life-cycle management of the biologic's analytical strategy
• Supporting System Development Life Cycle through development of electronic templates and protocols (i.e., SMP, D300), and documentation authoring, execution and reviewing

Position Qualifications:

Education Minimum Requirement:

Bachelor's degree in Biology, Chemistry, Biochemistry, or related scientific field with at least 2 years of relevant experience in analytical method execution, development, validation, and/or quality control (QC).

Required Experience and Skills:

• Understanding and experience with bioassays, specifically immunoassays (such as ELISA, EIA) or other binding-based assay technology.
• Ability to independently follow procedures and work within a cross-functional team to drive projects requiring coordination between multiple individuals or multiple representatives from other groups/departments.
• Ability to think critically and learn new techniques
• Good technical communication (oral and written), interpersonal, and teamwork skills
• Self-motivated with a positive attitude

Preferred Experience and Skills:

• Experience working in a Good Manufacturing Practices (cGMP) laboratory environment in the area of large molecules (biologics, vaccine) with experience in Immunochemical analytical Methods
• Knowledge of receptor pharmacology and 4PL curve analysis
• Experience with GMP compliance
• Familiarity with assay transfers, and equivalence studies
• Experience with deviation management.
• Experience with Electronic Notebook and LIMS systems.
• Experience with SoftMax Pro template creation
• Experience authoring technical documents
• Technical aptitude and desire to learn new equipment and associated software to enable digital build capabilities.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.

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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:

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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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote".

The salary range for this role is
$85,600.00 - $134,800.00

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:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Adaptability, Adaptability, Analytical Development, Analytical Method Development, Animal Vaccination, Antibody Detection, Biochemistry, Cell-Based Assays, Communication, Enzyme Linked Immunosorbent Assay (ELISA), Global Manufacturing, GMP Compliance, Good Manufacturing Practices (GMP), Immunoassays, Immunochemistry, Interpersonal Relationships, Laboratory Information Management System (LIMS), Laboratory Techniques, Mammalian Cell Culture, Real Time Polymerase Chain Reaction (qPCR), Self Motivation, Social Collaboration, Standard Operating Procedure (SOP) Writing, Systems Development Lifecycle (SDLC), Technical Communication {+ 3 more}

Preferred Skills:

Job Posting End Date:
09/17/2025
*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.

Requisition ID:R365315