Senior Scientist - Analytical Commercialization Technology (ACT)

Merck; New Jersey; On-site; USD 120,000 - 190,000; Full time

Job summary

Merck in Rahway, NJ seeks a Senior Scientist to advance analytical development for late-stage biopharmaceutical products. You will apply UHPLC/HPLC, GC, UV/IR, and other techniques to drive drug product characterization and method validation in a cGMP setting.

The role emphasizes data-driven decision making, cross-functional collaboration, and preparation of CMC documentation for global regulatory submissions, with potential for technology transfer and process scale-up.

Qualifications

• PhD in Chemistry or MS with 5+ years of pharma development experience.
• Proficient in analytical techniques and problem-solving in drug product development.
• Strong communication and collaboration across cross-functional teams.

Responsibilities

• Apply advanced analytical tools to solve development challenges and drive insights.
• Analyze data and trends to support product development and characterization.
• Develop and validate robust analytical methods for cGMP environments.
• Conduct drug product testing and investigations; support scale-up and validation.
• Prepare CMC documents for regulatory submissions and enable tech transfer.
• Collaborate in a multidisciplinary team to advance biomedical programs.

Skills

Analytical Method Development

Chemometrics

Chromatography

Data-Driven Decision Making

Mass Spectrometry Based Proteomics

Method Validation

Process Analytical Technology

Spectroscopy

Synthetic Biology

Chemical Proteomics

Chemistry Knowledge

Education

PhD in Chemistry

MS in Analytical Chemistry

Tools

UHPLC/HPLC

Gas Chromatography

UV Spectroscopy

IR Spectroscopy

Karl Fischer Titration

Dissolution Testing

Job description

We aspire to be the premier research-intensive biopharmaceutical company. Our company is at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

The Analytical Commercialization Technology (ACT) group is seeking applicants for a Senior Scientist position available at the Rahway, NJ and West Point, PA sites. ACT is an R&D group responsible for analytical development of late-stage pharmaceutical products. The successful candidate will utilize innovative analytical characterization technologies to drive pharmaceutical drug product development and commercialization.

The Senior Scientist responsibilities include, but not limited to problem solving with the use of advanced analytical tools, data analysis with the use of statistical tools to drive product development and characterization, development and validation of robust analytical methods, drug product testing and analytical investigations in a cGMP environment, drug product and manufacturing process characterization, drug product stability studies, specification development, manufacturing process scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and technology transfer for commercial manufacture. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment.

Responsibilities

• Utilize advanced analytical tools for problem-solving


• Analyze data for technical insights and trending


• Develop and validate robust analytical methods


• Conduct drug product testing and analytical investigations in a cGMP environment


• Characterize drug products and manufacturing processes


• Perform drug product stability studies


• Develop specifications and support manufacturing process scale-up and validation


• Prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions


• Facilitate technology transfer for commercial manufacture


• Collaborate in a dynamic, integrated, and multidisciplinary team environment

Qualifications

Required

• PhD in Chemistry or related discipline with no experience required OR


• Master of Science (MS) in Analytical Chemistry or related discipline with at least five (5) years of relevant pharmaceutical development experience.


• Strong knowledge and hands-on experience in chemistry and common analytical techniques


• Demonstrated problem-solving ability


• Excellent verbal and written communication skills


• Demonstrated creativity and strong interpersonal skills


• Ability to work in a team environment with cross-functional interactions

Preferred

• Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High-Performance Liquid Chromatography (UHPLC/HPLC), Gas Chromatography, Ultraviolet (UV) and Infrared (IR) spectroscopy, Karl Fischer titration, and dissolution testing .

Required Skills

• Analytical Method Development, Chemical Proteomics, Chemical Synthesis, Chemometrics, Chromatography, Data-Driven Decision Making, Mass Spectrometry Based Proteomics, Method Validation, Motivation Management, Process Analytical Technology (PAT), Protein Chromatography, Spectroscopy, Synthetic Biology

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:

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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 o