Principal Scientist, Small Molecule Analytical Chemistry

Merck; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Bonus eligibility

Comprehensive benefits package

Job summary

Merck in Rahway, NJ and West Point, PA seeks a Principal Scientist to lead the Analytical Commercialization Technology group within ACiDS. You will drive analytical method development, validation, drug product testing, and cGMP investigations to support late-stage drug product development and commercialization.

You will mentor scientists, coordinate technology transfers, and collaborate across regulatory, research, and manufacturing to ensure robust CMC documentation and regulatory readiness.

Qualifications

• PhD in Analytical Chemistry or related discipline with seven or more years of small molecule pharmaceutical development experience; OR MS with ten or more years.
• Strong background with analytical techniques such as UHPLC/HPLC, dissolution, GC, UV, IR, and Karl Fischer titration.
• Extensive experience with method development and validation.
• Significant experience authoring CTD sections for regulatory submissions (IND, NDA, MAA, JNDA, etc.).
• Demonstrated problem-solving ability and excellent communication skills.

Responsibilities

• Lead a team of scientists in analytical method development and validation in a cGMP environment.
• Oversee drug product testing, characterization, stability studies, and specification development.
• Support manufacturing process scale-up and validation activities.
• Prepare CMC documents for global regulatory submissions and respond to regulatory questions.
• Collaborate with cross-functional groups including regulatory, research, and manufacturing.
• Coordinate development efforts across multiple projects and mentor junior scientists.

Skills

UHPLC/HPLC

Dissolution

Gas Chromatography

UV spectroscopy

IR spectroscopy

Karl Fischer

method development

regulatory submissions CTD

team leadership

mentoring

analytical technology transfers

Education

PhD in Analytical Chemistry

MS in Analytical Chemistry

Tools

LC/MS

GC/MS

UHPLC

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 are seeking a Principal Scientist to join our Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) at our Rahway, NJ and West Point, PA sites. This is an exciting opportunity to lead a highly collaborative team of scientists utilizing innovative analytical characterization technologies to drive late-stage small molecule pharmaceutical drug product development and commercialization.

The Principal Scientist responsibilities include, but not limited to, analytical method development and validation, 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 responses to regulatory questions.

The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. Effective interaction with other technical, regulatory, research and manufacturing groups is critical. The incumbent is required to work with teams to effectively coordinate drug product development efforts and lead the progress for multiple projects. The incumbent is also expected to mentor other scientists as well as build/maintain the scientific capabilities of our organization.

Responsibilities

• Lead a team of scientists in analytical method development and validation, drug product testing, and analytical investigations in a cGMP environment.


• Oversee drug product and manufacturing process characterization, stability studies, and specification development.


• Support manufacturing process scale-up and validation.


• Prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions and respond to regulatory questions.


• Collaborate effectively with technical, regulatory, research, and manufacturing groups.


• Coordinate drug product development efforts and lead progress for multiple projects.


• Mentor other scientists and build/maintain the scientific capabilities of our organization.

Qualifications

Required

• PhD in Analytical Chemistry or related discipline with seven or more (7+) years of relevant small molecule pharmaceutical development experience; OR MS with ten or more (10+) years.


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


• Extensive experience with method development and validation.


• Significant experience authoring relevant CTD sections of regulatory submissions (IND, NDA, MAA, JNDA, etc.).


• 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.


• Experience in mentoring and leading teams.


• Significant experience in analytical technology transfers.


• Demonstrated effective planning and execution of regulatory strategies.

Preferred

• Experience with hyphenated analytical techniques such as LC/MS and GC/MS with proven ability in troubleshooting these methodologies.

Required Skills:

Academic Presentations, Bioconjugation, Computational Chemistry, Creativity, Data Analysis, High-Throughput Experimentation (HTE), Organic Synthesis, Professional Networking, Project Leadership, Research Proposal Development, Scientific Leadership, Scientific Literature Search, Strategic Thinking, Structure Based Drug Design, Synthetic Chemistry

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/16/2026

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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

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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

$173,200.00 - $272,600.00

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 .