Principal Scientist, Small Molecule Analytical Chemistry

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Paid time off

Job summary

HireLifeScience in Rahway, NJ, leads analytical commercialization for late-stage drug products. The Principal Scientist will drive method development, validation, and drug product testing in a collaborative, cross-functional team.

Responsibilities include CMC document preparation for regulatory submissions and mentoring scientists, with a focus on scale-up and regulatory readiness across global programs.

Qualifications

• PhD or MS with extensive pharma development experience in small molecules.
• Proven ability to develop and validate analytical methods in cGMP.
• Experience authoring CTD sections for regulatory submissions.

Responsibilities

• Lead a team in analytical method development and validation.
• Oversee drug product testing, characterization, and stability studies.
• Prepare CMC documents for global regulatory submissions.
• Collaborate with regulatory, manufacturing, and research groups.
• Mentor scientists and build analytical capabilities.
• Coordinate drug product development for multiple projects.

Skills

Academic Presentations

Bioconjugation

Computational Chemistry

Creativity

Data Analysis

High-Throughput

Organic Synthesis

Professional Networking

Project Leadership

Research Proposal

Leadership

Literature Search

Strategic Thinking

Structure Based Drug Design

Synthetic Chemistry

Education

PhD in Analytical Chemistry or related discipline

MS in Analytical Chemistry or related discipline

Tools

UHPLC/HPLC

Dissolution

Gas Chromatography

UV Spectroscopy

IR Spectroscopy

Karl Fischer Titration

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.

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 salary range for this role is $173,200.00 - $272,600.00

• 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 .

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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

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.

Requisition ID: R420050