Associate Director, Bioanalytics - Global Preclinical Development

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

Required

• •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

Preferred Skills:

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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 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
• This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. 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

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