Job Description

The PDMB Regulated Bioanalytics Department is seeking an Associate Principal Scientist for the Molecular Lab team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our Company's 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's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

An R4 Associate Principal Scientist in regulated bioanalytics, Late Development Vaccines, plays a strategic leadership role in the development, validation, and implementation of molecular based bioanalytical methods for the quantitative and qualitative analysis for our vaccines pipeline, ensuring adherence to regulatory standards and guidelines. This position involves defining project objectives, managing timelines, and overseeing the technical execution of complex bioanalytical studies while ensuring compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). The Associate Principal Scientist will lead cross-functional teams, providing mentorship and guidance to junior scientists and fostering a collaborative environment that promotes scientific excellence and innovation. In this role, the individual will also be responsible for preparing regulatory submissions and critical documentation, ensuring that data integrity and quality are maintained throughout the process. Strong expertise in molecular-based bioanalytical techniques, along with a comprehensive understanding of regulatory compliance and quality assurance requirements, is essential. Additionally, the Associate Principal Scientist must exhibit exceptional problem-solving abilities, strategic thinking, and excellent communication skills to effectively convey complex scientific concepts to both technical and non-technical stakeholders, while driving initiatives for continuous improvement 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 molecular biology based methods including PCR, qPCR, DNA extraction, and related techniques and lead the development, qualification, validation, and troubleshooting of bioanalytical methods.

• Demonstrate expertise with laboratory automation (e.g., robotic platforms, liquid handlers) to drive end-to-end fully automated assay to support late stage clinical testing

• Apply statistical methods and software tools for rigorous data analysis, ensuring adherence to data integrity principles.

• Summarize, interpret, and communicate bioanalytical data clearly and accurately.

• Devise innovative solutions for method optimization and validation challenges.

• Prepare high-quality regulatory documents, scientific reports, and presentations for diverse audiences.

• Lead, mentor, and coach junior scientists within the PDMB Regulated Bioanalytics Department.

• Collaborate effectively with cross-functional teams across PDMB and external partners.

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

• Ensure compliance with all safety and environmental regulations, holding team members accountable for maintaining a safe working environment.

• Stay current with emerging bioanalytical technologies and industry developments, driving continuous improvement.

• Represent the department during audits, influencing positive outcomes through thorough preparation and knowledge.

• Maintain keen attention to detail and uphold high standards of quality, compliance, and scientific rigor.

• Lead quality assurance practices and participate in laboratory audits to ensure regulatory compliance.

Required Experience & Skills

• Deep expertise in molecular based bioanalytical method development, qualification, validation, and troubleshooting.

• Strong knowledge and practical experience with data management and integrity practices in regulated environments.

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

• Strong analytical thinking and problem-solving skills to address complex scientific and technical challenges.

• Leadership experience with demonstrated ability to mentor junior scientists and foster collaboration.

• Comprehensive understanding of regulatory compliance requirements and quality assurance practices.

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

• Strong organizational skills with the ability to manage multiple projects concurrently.

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

• Adaptability and openness to feedback, with a continuous improvement mindset.

• Enterprise mindset with the ability to align departmental goals with broader organizational objectives

Preferred Experience & Skills

• Experience with advanced molecular biology based technologies and automation platforms.

• 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, budgets, and resources effectively.

• 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 Development, Assay Development, Bioanalysis, Bioanalytical Techniques, Cell-Based Assays, Communication, Computer Science, Data Analysis, Detail-Oriented, DMPK, GMP Compliance, Good Manufacturing Practices (GMP), GxPs, Immunoassays, Immunochemistry, Immunology, Innovation, Laboratory Automation, Laboratory Informatics, Laboratory Information Management System (LIMS), Machine Learning, Mentorship, Microbiology, Molecular Biology, Neutralization Assays {+ 6 more}

Preferred Skills:

Job Posting End Date:

09/26/2025

*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.