Associate Principal Scientist, Process Analytical Technologies

Merck; Rahway (NJ); Hybrid; USD 142,400 - 224,100; Full time

Job summary

Merck in Rahway, NJ, is seeking an experienced Associate Principal Scientist to lead the development and implementation of Process Analytical Technologies (PAT). The role includes providing technical leadership, developing standardized analytical platforms for PAT methods, and collaborating with cross-functional teams. Candidates should have extensive experience in PAT, spectroscopy, and chromatography. The position offers a hybrid work model and a competitive salary range of $142,400 to $224,100, with additional bonuses.

Qualifications

• Minimum of 12 years of relevant industry experience.
• Demonstrated experience in PAT.
• Strong technical background in spectroscopy and chromatography.

Responsibilities

• Provide technical leadership for deployment of PAT methods.
• Design and develop standardized analytical platforms.
• Lead scale-up activities and technology transfer.

Skills

Adaptability

Analytical Method Development

Assay Development

Biodesign

Biological Assay Development

Cell-Based Assays

Chemical Engineering

Chemometrics

Chromatographic Techniques

Chromatography

Cross-Functional Collaboration

Cross-Functional Teamwork

External Collaboration

High Resolution Mass Spectrometry (HRMS)

Liquid Chromatography-Mass Spectrometry (LC-MS)

Mass Spectrometry Analysis

Process Analytical Technology (PAT)

Project Leadership

Real Time Monitoring

Education

B.S. in chemistry, biochemistry, biotechnology, bioengineering, chemical engineering, or a related discipline

M.S. with at least 8 years relevant experience

Ph.D. with at least 4 years relevant experience

Job description

Overview

We are seeking an experienced and innovative Associate Principal Scientist to join the Process Analytical Technologies (PAT) team within Analytical Enabling Capabilities. In this role, you will collaborate with a cross-functional, highly engaged team to advance the development pipeline and support commercial manufacturing. The successful candidate will lead the development, validation, and implementation of in-line, on-line, and at-line PAT solutions for both small- and large-molecule modalities. Join our company and contribute to our mission of delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Responsibilities

• Provide technical leadership for systematic assessment and deployment of in-line, on-line, and at-line PAT methods across small- and large-molecule programs.
• Design and develop standardized analytical platforms to enable PAT implementation, including real-time monitoring and rapid shop-floor analytics.
• Develop, validate, and implement PAT methods (in-line, on-line, at-line) to monitor and control process parameters and product quality attributes.
• Lead scale-up activities and technology transfer of PAT applications to commercial manufacturing.
• Partner with capital project and facility teams to design and establish integrated PAT infrastructure aligned with the Launch Preparedness strategy.
• Create integrated control strategies that leverage PAT platforms to enable robust, highly capable manufacturing processes across modalities (e.g., small molecule drug product, biologics, and vaccines).
• Prepare and maintain scientific documentation and validation packages for PAT methods; contribute content for regulatory submissions.
• Interact with global regulatory agencies as needed to support acceptance of PAT-based process control and release strategies.

Qualifications

• B.S. in chemistry, biochemistry, biotechnology, bioengineering, chemical engineering, or a related discipline with a minimum of 12 years of relevant industry experience; or M.S. with at least 8 years; or Ph.D. with at least 4 years.
• Demonstrated experience in PAT.
• Strong technical background in spectroscopy (Raman, FTIR, NIR), chromatography, and chemometric/modeling approaches.
• Proven track record of scientific contributions (peer-reviewed publications or equivalent technical outputs).

Preferred

• Experience preparing PAT content for regulatory filings and interacting with regulatory agencies.
• Experience with PAT implementation in commercial manufacturing and technology transfer.
• Strong collaborative and interpersonal skills; ability to work across functions and with external partners.
• Project leadership and the ability to manage multiple priorities in a fast-paced environment.

Required Skills

• Adaptability, Analytical Method Development, Assay Development, Biodesign, Biological Assay Development, Cell-Based Assays, Chemical Engineering, Chemometrics, Chromatographic Techniques, Chromatography, Cross-Functional Collaboration, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Process Analytical Technology (PAT), Project Leadership, Real Time Monitoring

Additional Information

• US And Puerto Rico Residents Only
• Our company is committed to inclusion and provides accommodations during the application or hiring process if needed.
• As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on protected characteristics.
• Salary range: $142,400.00 - $224,100.00. Eligible for annual bonus and long-term incentive, if applicable.
• Hybrid work model in the U.S. with three on-site days per week (details in posting).
• Travel requirements: 10%

Requisition ID: R394030