Associate Director, Bioanalytics - Global Preclinical Development

3082 Intervet Inc. USA

Rahway (NJ)

On-site

USD 142,000 - 224,000

Full time

4 days ago
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Job summary

Merck & Co., Inc. in Rahway, NJ seeks an Associate Director of Bioanalytics to lead the Rahway Bioanalytical Laboratory within Global Preclinical Development.

You will provide scientific and operational leadership for bioanalytical activities across research, preclinical, and clinical programs, ensuring timely, high-quality data and regulatory-compliant documentation. The role emphasizes team development, mass spectrometry-based analysis, method validation, data integrity, and CRO oversight,

Qualifications

  • Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry or related discipline with minimum six years of industry experience; or Master's with minimum ten years of industry experience.
  • Demonstrated experience in bioanalytical method development, validation and biological sample analysis in regulated environments.
  • Experience in GLP-regulated environments and strong data integrity/regulatory documentation knowledge.
  • Proven track record leading scientists and laboratory teams, including coaching and development.
  • Strong expertise in quantitative bioanalysis, especially mass spectrometry.
  • Preferred experience supporting regulatory submissions for veterinary or human pharmaceuticals and CRO/external lab oversight.
  • Experience with additional bioanalytical technologies such as immunoassays or ligand-binding assays.
  • Knowledge of pharmacokinetics and/or drug metabolism.
  • Experience implementing laboratory automation and regulated digital data workflows.
  • Project-management experience.

Responsibilities

  • Lead the Rahway Bioanalytical Laboratory with scientific and operational oversight.
  • Drive automation, digital technologies, and data workflows to improve efficiency and compliance.
  • Develop and mentor the BioAnalytics team through performance management.
  • Oversee method development, qualification, validation and sample analysis with emphasis on mass spectrometry.
  • Ensure data integrity, documentation, and regulatory compliance.
  • Review data, methods, protocols, and reports for regulatory submissions.
  • Provide scientific guidance and drive continuous improvement of technologies and processes.
  • Partner cross-functionally to define bioanalytical strategies for development programs and regulatory interactions.
  • Oversee external bioanalytical activities by CROs and other labs.
  • Evaluate emerging scientific and regulatory developments to advance capabilities.

Skills

Automated Cell Culture
Bioanalytical Method Development
Bioreactor Operation
Data Science
Financial Research
Interpersonal Relationships
In Vivo Studies
Membrane Filtration Systems
Product Development
Results-Oriented
Stakeholder Communications
Technical Mentoring
Technical Transfer
Transcriptome Analysis
Trend Knowledge

Education

Ph.D. in analytical chemistry / bioanalytical chemistry / pharmaceutical sciences / biochemistry or related discipline
Master's degree in a relevant scientific discipline

Tools

Regulatory compliant data management

Job description

Job Description We aspire to be the premier research-intensive biopharmaceutical company. At our company, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join us in our mission to make a difference.

The Associate Director, Bioanalytics leads the Rahway Bioanalytical Laboratory within Global Preclinical Development, providing scientific, operational, regulatory, and people leadership for bioanalytical activities supporting research, business, preclinical, and clinical development programs for veterinary pharmaceuticals. The role is accountable for the timely delivery of high-quality, scientifically sound, and regulatory-compliant bioanalytical data and documentation, while developing the Rahway Bioanalytics team and collaborating with internal and external partners.

Responsibilities
  • Lead the Rahway Bioanalytical Laboratory, including scientific and operational oversight, prioritization, resource planning, and delivery of project commitments.
  • Drive laboratory automation, digital technologies, and integrated data workflows to increase efficiency, data integrity, compliance, and scientific capabilities.
  • Lead and develop the Bioanalytics team through performance management, coaching, and capability building.
  • Oversee bioanalytical method development, qualification, validation, and sample analysis, with particular emphasis on mass spectrometry.
  • Ensure scientific quality, data integrity, documentation, and compliance with GLP, internal procedures, and regulatory requirements.
  • Review bioanalytical data, methods, protocols, and reports to ensure scientific rigor and suitability for regulatory submissions.
  • Provide scientific guidance, resolve complex bioanalytical issues, and drive continuous improvement of technologies, processes, and capabilities.
  • Partner across functions to define and execute bioanalytical strategies and provide expertise to development programs and regulatory interactions.
  • Oversee external bioanalytical activities performed by contract research organizations and other laboratories.
  • Evaluate emerging scientific, technological, and regulatory developments to advance laboratory capabilities.
Qualifications
  • Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry or a related scientific discipline with a minimum of six (6) years of relevant industry experience; or Master's degree in a relevant scientific discipline with a minimum of ten (10) years of relevant industry experience.
  • Demonstrated experience in bioanalytical method development, validation and biological sample analysis in a regulated pharmaceutical, animal health or comparable environment.
  • Experience working in a GLP-regulated environment and a strong understanding of data integrity and regulatory documentation expectations.
  • Demonstrated experience leading scientists and/or laboratory teams, including scientific direction, prioritization, coaching and development.
  • Strong scientific expertise in quantitative bioanalysis, particularly mass spectrometry.
  • Preferred Experience supporting regulatory submissions for veterinary or human pharmaceuticals and interacting with regulatory, quality, or compliance organizations.
  • Experience managing bioanalytical activities performed by CROs or external laboratories.
  • Experience with additional bioanalytical technologies, such as immunoassays or ligand-binding assays.
  • Knowledge of pharmacokinetics and/or drug metabolism.
  • Experience implementing laboratory automation, computerized laboratory systems, and regulated digital data workflows.
  • Project-management experience.
Required Skills
  • Automated Cell Culture
  • Bioanalytical Method Development
  • Bioreactor Operation
  • Data Science
  • Financial Research
  • Interpersonal Relationships
  • In Vivo Studies
  • Membrane Filtration Systems
  • Product Development
  • Results-Oriented
  • Stakeholder Communications
  • Technical Mentoring
  • Technical Transfer
  • Transcriptome Analysis
  • Trend Knowledge
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.

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: EEOC Know Your Rights EEOC GINA Supplement

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

The primary location for this posting is: USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $142,400.00 - $224,100.00

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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position.

If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information: 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: 1st - Day Valid Driving License: No Hazardous Material(s): n/a

Job Posting End Date: 11/17/2026 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring…

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