Job Description

The PDMB Regulated Bioanalytics Department is seeking an Associate Principal Scientist for the Serology Lab team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our company new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g. PCR), serology (e.g. ligand binding immunoassays), and cell-based assays (e.g. neutralization assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our Company Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

We are seeking a strategic and experienced Associate Principal Scientist in Regulated Bioanalytics to join our team. In this pivotal role, you will lead the development, validation, and implementation of bioanalytical methods for the quantitative analysis of pharmaceuticals and biomarkers, ensuring compliance with regulatory standards and guidelines. You will define project objectives, manage timelines, and oversee the technical execution of complex bioanalytical studies while adhering to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).

As an Associate Principal Scientist, you will mentor junior scientists, foster a collaborative environment, and prepare regulatory submissions and critical documentation, ensuring data integrity and quality throughout the process. Your strong expertise in bioanalytical techniques, regulatory compliance, and quality assurance will be essential in driving continuous improvement initiatives within the bioanalytical function.

Education Minimum Requirement

• B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with at least 12 years, M.S. with at least 8 years, or Ph.D. with at least 4 years hands-on experience in related field

Responsibilities

• Demonstrate expertise in relevant bioanalytical techniques

• Lead the development, qualification, validation, and troubleshooting of bioanalytical methods

• Utilize statistical methods and software for data analysis

• Summarize and interpret bioanalytical data while maintaining data integrity principles

• Apply strong analytical thinking and problem-solving skills to complex scientific challenges

• Devise innovative solutions for method optimization and validation issues

• Prepare regulatory documents and scientific reports with excellent written and verbal communication skills

• Lead, mentor, and coach junior scientists within the department

• Collaborate effectively with cross-functional teams

• Ensure adherence to safety and environmental regulations

• Develop timelines and oversee multiple studies simultaneously with strong organizational and project management skills

• Stay updated with emerging technologies and developments in the bioanalytical field

• Represent the department during audits, influencing positive outcomes

• Maintain high standards of quality and compliance with keen attention to detail

• Ensure familiarity with quality assurance practices and audits in a laboratory setting

Required Experience & Skills

• Proven track record of leading complex bioanalytical studies and managing cross-functional teams

• Strong expertise in bioanalytical techniques such as ELISA, or other relevant methodologies for method development, qualification, validation, and troubleshooting

• Excellent written and verbal communication skills, capable of conveying complex technical information to both technical and non-technical stakeholders

• Experience representing departments during audits and managing audit-related activities

• In-depth knowledge of regulatory compliance (FDA, EMA, ICH guidelines) and quality assurance practices (GLP, GxP)

• Experience with data management and integrity practices in a regulated laboratory setting

• Strong organizational and project management skills to oversee multiple studies simultaneously

• Exceptional problem-solving abilities and strategic thinking, complemented by strong emotional intelligence, active listening, and adaptability to change

• Demonstrated ability to mentor and develop junior scientists and foster collaboration

• Commitment to safety, environmental regulations, and promoting a safe laboratory culture

• Demonstrate a growth mindset that is adaptable and open to feedback for continuous improvement, alongside an enterprise mindset that aligns departmental goals with broader organizational objectives

Preferred Experience & Skills

• Experience with advanced automation platforms for bioanalytical assays

• Familiarity with Laboratory Information Management Systems (LIMS) and electronic data capture systems

• Proficiency in statistical analysis and relevant software for bioanalytical data interpretation

• Ability to lead initiatives for adopting new technologies and improving bioanalytical workflows

• Proven ability to develop and manage project plans for multiple assays

• Demonstrated success in cross-functional team leadership and collaboration

• Experience in late-stage clinical trial bioanalytics or vaccine development

• Strong strategic thinking skills with a focus on innovation and scientific excellence

• Experience performing computer systems validations

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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.

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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

$139,600.00 - $219,700.00

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Assay, Assay, Audit Preparations, Bioanalysis, Bioanalytical Techniques, Cell-Based Assays, Communication, Computer Science, Cross-Team Collaboration, Detail-Oriented, GLP Regulations, Good Manufacturing Practices (GMP), GxPs, Immunoassays, Immunochemistry, Immunology, Laboratory Informatics, Laboratory Information Management System (LIMS), Machine Learning, Mentorship, Microbiology, Molecular Biology, Project Leadership, Project Management, Regulatory Compliance {+ 3 more}

Preferred Skills:

Innovation, Troubleshooting

Job Posting End Date:

09/29/2025

*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:R366445