Job Description
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
Preferred Skills:
Current Employees apply HERE
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.
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.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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.
