Scientist, GMP Analytical

Merck; Rahway (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Merck & Co. in Rahway, NJ, is seeking an analytical chemist to contribute to GMP method validation and analytical development for APIs and formulations. The role emphasizes collaboration with R&D and tight data integrity in a fast-paced pharmaceutical setting.

You will work with chromatography, dissolution, and physical chemistry techniques, ultimately supporting high-priority drug candidates while maintaining rigorous SOPs and documentation.

Qualifications

• Minimum 1 year of pharmaceutical experience.
• Strong technical skills and proficiency in analytical laboratory techniques.
• GMP experience and understanding of GMP processes and SOP governance.
• Ability to work under the direction of a laboratory supervisor.

Responsibilities

• Execute GMP method validation for APIs, excipients, and formulated drug products (tablets, topicals, solutions).
• Support pilot manufacturing plant testing of APIs, excipients, packaging materials, and cleaning samples.
• Collaborate with R&D project leads to assess needs, timelines and prioritization.
• Maintain high-quality documentation and data integrity; prepare technical reports.
• Support analytical development of high-priority drug candidates.

Skills

Analytical Chemistry

Chromatography

HPLC

GC

Dissolution

Karl Fischer

Particle size analysis

Viscometry

Laboratory Techniques

GMP

Education

Bachelor's degree in Chemistry, Pharmacy, or other scientific discipline

Tools

SDLC

Job description

Job Description

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Job Description

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.

The Professional In This Position Will

• Execute GMP method validation for active pharmaceutical ingredients (APIs), excipients, and formulated drug products (e.g., tablets, topicals, solutions, implants).
• Support a pilot manufacturing plant through the testing of APIs, excipients, packaging materials, and cleaning samples.
• Work closely with R&D project leads to assess project needs, timelines, and prioritization.
• Understand GMP processes and work in adherence to SOPs and method protocols.
• Maintain high-quality documentation and data integrity, analyze and interpret data, and prepare technical reports, with the support of senior scientists and managers in the organization.
• Support the analytical development of high-priority drug candidates.

The candidate will be trained to develop excellent laboratory skills and a solid understanding of analytical and physical chemistry. Techniques often used by persons in this position include chromatography (e.g., HPLC, GC), dissolution, physical characterizations (e.g., particle size analysis, viscometry, density), and general/wet chemistry methods.

This position requires the ability to work well in a highly collaborative environment as well as excellent oral and written communication skills.

Education Minimum Requirement

Bachelor's degree in Chemistry, Pharmacy, or other scientific discipline

Required Experience And Skills

• Minimum 1 year of previous pharmaceutical experience.
• Qualified candidates must have strong technical skills and a proficiency in analytical laboratory techniques.
• Individual should have some work experience in a GMP environment and an understanding of GMP processes and SOP governance.
• Ability to work under the general direction of a laboratory supervisor is required.

Preferred Experience And Skills

• Strong oral and written communication skills, including experience authoring technical documents.
• Demonstrated knowledge of multiple analytical techniques such as: HPLC, GC, Dissolution, Karl Fischer, Particle size, Viscometry, Texture Analysis, Auto titration, etc.
• Familiarization with USP and Ph. Eur. Monographs.
• Familiarization with software validation (SDLC)
• Attention to detail, customer focus, and continuous improvement are also important to this role.

The ideal candidate will have a personal drive for results and a demonstrated history of achievement in a pharmaceutical laboratory environment.

Required Skills

• Adaptability, Adaptability, Analytical Chemistry, Antibodies, Biochemistry, Bioprocess Engineering, Chemical Engineering, Chemistry, Chromatography, Data Analysis, Innovation, Laboratory Analytical Techniques, Laboratory Management, Laboratory Operations, Laboratory Research, Laboratory Techniques, Laboratory Testing, Liquid Chromatography (LC), Materials Science, Molecular Biology, Molecular Cloning, Next Generation Science Standards, Pharmaceutical Industry, Pharmaceutical Sciences, Pharmaceutics {+ 9 more}

<