Senior Scientist, Analytical R&D (Onsite)

Merck; New Jersey; On-site; USD 110,000 - 160,000; Full time

Job summary

Merck in Rahway, NJ, seeks a Senior Scientist in the Pharmaceutical Analytical Sciences group. You will drive analytical development for various drug substances and dosage forms, leveraging LC, MS, NMR, and other advanced tools under GMP conditions.

Lead cross-functional teams and contribute to regulatory submissions throughout development. Ideal candidates hold a PhD (or relevant advanced degree with industry experience) and have strong publication history, communication, and leadership skills.

Qualifications

• PhD required in chemistry/pharmaceutical sciences or related field.
• Advanced degree holders should have strong analytical and regulatory-writing capabilities.
• Experience with GMP, analytical method development, and leadership in cross-functional teams.

Responsibilities

• Lead analytical development for small molecules, peptides, and oligonucleotides.
• Design studies to understand synthesis routes, formulations, and manufacturing processes.
• Develop analytical methods for GMP release and shelflife testing of clinical supplies.
• Provide leadership in technology teams and project development.
• Prepare regulatory submission documents and respond to agency inquiries.
• Document experimental work thoroughly and communicate results to teams.

Skills

Analytical Method Development

Assay Development

Bioanalytical Analysis

Chemistry

Drug Development

GMP Environments

Innovative Thinking

Liquid Chromatography (LC)

Mass Spectrometry (MS)

Method Development

Nuclear Magnetic Resonance (NMR)

Pharmaceutical Industry

Regulatory Submissions

Strategic Thinking

Technical Writing

Education

PhD in Chemistry, Pharmaceutical Science, or related discipline

Master's degree in Chemistry, Pharmaceutical Sciences, or related discipline with 3+ years pharma experience

Bachelor's Degree in Chemistry, Pharmaceutical Sciences, or related discipline with 7+ years industry experience

Job description

Job Description

The Pharmaceutical Analytical Sciences group has an opening for a Senior Scientist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

In your role as Senior Scientist, you will be part of a team developing innovative analytical methodologies for early-to late-phase programs with application to drug substance and a broad array of drug product dosage forms, combination products, and modalities through analytical characterization, imaging tools, and data analysis. You would also contribute towards regulatory submissions to enable clinical trials.

Your main responsibilities include:

• Driving solutions to analytical development challenges for synthetic small molecule, peptide, and oligonucleotide active pharmaceutical ingredients and pharmaceutical products using conventional and novel technologies.
• Designing scientific studies to inform the selection and deep understanding of synthetic routes, formulation compositions, and manufacturing processes.
• Implementing analytical methods for laboratory development, as well as release and shelflife assessment of clinical supplies under good manufacturing practice (GMP) conditions.
• Providing leadership not only on drug development pipeline projects, but also innovative technology teams shaping analytical methods and tools of the future.
• Authoring regulatory submission documents across the project development lifecycle, as well as responding to agency questions.
• Documenting work in a detailed and timely manner.
• Collaborating effectively with internal and external partners.
• Presenting results of experiments and innovation efforts to project teams and at various cross-functional forums.
• Engaging in the external scientific community, e.g., through participation in professional organizations, conferences, and publications.

Travel Requirements: 5-10% Travel.

Education Minimum Requirements:

• PhD in Chemistry, Pharmaceutical Science, or related discipline.
• Master's degree in Chemistry, Pharmaceutical Sciences, or related discipline plus at least 3 years of pharmaceutical industry experience.
• Bachelor's Degree in Chemistry, Pharmaceutical Sciences, or related discipline, plus at least 7 years of industry experience.

Required Experience and Skills:

• A proven record of strong technical problem solving and innovative research experience, supported by scientific publications.
• Excellent written and oral communication skills.
• Strong leadership, collaboration, and interpersonal skills.

Preferred Experience and Skills:

• Experience with large molecule characterization (oligonucleotides, enzymes, peptides, etc.).
• Chromatography (e.g., LC, GC) method development, analysis, and troubleshooting.
• Other advanced analytical techniques such as mass spectrometry or dissolution.
• Data science.

Required Skills:

• Analytical Method Development
• Assay Development
• Bioanalytical Analysis
• Chemistry
• Drug Development
• GMP Environments
• Innovative Thinking
• Liquid Chromatography (LC)
• Mass Spectrometry (MS)
• Method Development
• Nuclear Magnetic Resonance (NMR)
• Pharmaceutical Industry
• Regulatory Submissions
• Strategic Thinking
• Technical Writing

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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