Associate Principal Scientist, Regulated Bioanalytics (Pharmacokinetics)

Job Description

We are recruiting for an Associate Principal Scientist in Regulated Bioanalytics to serve as an advanced technical contributor responsible for the development, validation, and implementation of regulated bioanalytical methods to support quantitative analysis of therapeutic and biotherapeutic drug candidates.

Job Summary:    

• Provide technical leadership and sound regulatory judgment for bioanalytical assay development, qualification, validation, and sample analysis in compliance with applicable regulatory guidance and Good Laboratory Practice (GLP).
• Independently manage bioanalytical responsibilities for assigned development programs, including defining technical approaches, ensuring data quality and integrity, and meeting program timelines.
• Apply deep technical expertise to troubleshoot and resolve complex bioanalytical challenges, including those associated with novel or emerging drug modalities.
• Author, review, and contribute to high‑quality regulatory documentation and critical technical reports supporting preclinical and clinical development and regulatory submissions.
• Communicate complex scientific findings and recommendations effectively to cross‑functional colleagues and external collaborators to support informed decision‑making.
• Contribute to continuous improvement within the bioanalytical function through adoption of best practices, process optimization, and effective knowledge sharing.
• Serve as a technical mentor to junior scientists and a subject matter expert within regulated bioanalysis.
   

Key Responsibilities:

• Support late‑stage drug development activities, including bioanalytical readiness for pivotal studies and regulatory submissions.
• Demonstrate advanced expertise in regulated bioanalytical methods for quantifying therapeutic and biotherapeutic drug candidates and anti‑drug antibodies, using ligand‑binding assay–based platforms (e.g., Meso Scale Discovery, Gyrolab, Ella), LC‑MS methodologies, and emerging bioanalytical technologies.
• Provide scientific leadership and sound regulatory judgment for internal and external bioanalytical assay development, qualification, validation, and sample analysis in support of preclinical and clinical studies.
• Independently apply deep technical knowledge to adapt and extend established bioanalytical methodologies to address challenges in complex biological matrices and evolving development programs.
• Contribute to innovation by developing and implementing new approaches, hypotheses, or process improvements to address bioanalytical challenges associated with emerging and complex drug modalities.
• Author, review, and contribute to high‑quality regulatory documentation (e.g., IND‑ and BLA‑supporting modules), internal technical reports, and responses to regulatory questions.
• Effectively communicate complex scientific concepts and influences stakeholders, fostering informed decision‑making and, when appropriate, encouraging alternative perspectives through collaboration and scientific contribution.
• Strong organizational and project management skills to oversee multiple studies simultaneously.

QUALIFICATIONS:

Education:  

• Bachelor's (with 10+ years), Master's (with 6+ years) or Ph.D. (with 4+ years) in Chemistry, Analytical Chemistry, Molecular Biology, Immunology, Cell Biology, Biology, Biochemistry or a related Biological Sciences discipline and relevant experience.

 

Required Experience and Skills:

• Advanced experience in regulated bioanalysis for PK and/or immunogenicity, including developing, qualifying, and validating ligand-binding and/or LC–MS assays.
• Strong knowledge of global regulatory expectations, including writing and reviewing documents for IND/BLA submissions.
• Ability to lead bioanalytical strategy for development programs, delivering high-quality data on time.
• Experience troubleshooting complex bioanalytical issues and adapting methods for challenging matrices and changing program needs.
• Clear scientific writing and communication skills to present data, interpret results, and support cross-functional decisions.
• Strong project management skills to run multiple studies and priorities in a fast-paced environment.

Preferred Experience and Skills:

• Deep immunogenicity (ADA) experience, including assay design, validation strategy, and clinical data interpretation.
• Experience supporting bioanalytical strategy for complex and emerging modalities (e.g., peptides, multispecific antibodies, and other novel therapeutics).
• Hands-on experience across platforms (e.g., Meso Scale Discovery platform, Gyrolab, LC–MS), including choosing fit-for-purpose approaches and driving method/process improvements.
• Strong cross-functional leadership, including mentoring junior scientists and building best practices.

 #EligibleforERP

Required Skills:

Analytical Chemistry, Assay Development, Bioanalysis, Bioanalytical Techniques, Clinical Data Interpretation, Immunogenicity, IND Submission, Leadership, Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmacokinetics, Project Management, Regulatory Compliance, Regulatory Documents

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:

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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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The salary range for this role is

$142,400.00 - $224,100.00

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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/1/2026

*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.