Sr. Scientist, Analytical R&D

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

Job summary

Merck in Rahway, NJ seeks a Senior Scientist to advance analytical methodologies for small molecules and related dosage forms. You will design and execute studies, implement GMP-compliant methods, and provide leadership across development programs.

Responsibilities include collaboration with internal and external partners, regulatory documentation, and presenting results in cross-functional forums. Travel is 5-10%.

Qualifications

• PhD or equivalent with strong publication record preferred.
• Experience with GMP environments and regulatory documentation.
• Proven ability to design and execute analytical development studies.

Responsibilities

• Drive solutions to analytical development challenges for small molecules, peptides, and oligonucleotide APIs and products.
• Design studies to understand synthetic routes, formulations, and manufacturing processes.
• Implement analytical methods for lab development as well as release and shelf-life assessment under GMP conditions.
• Lead innovation teams shaping future analytical methods and tools.

Skills

Adaptability

Analytical Method Development

Assay Development

Bioanalytical Analysis

Biochemical Assays

Cell-Based Assays

Chromatographic Techniques

GMP Environments

Innovative Thinking

NMR Analysis

PAT

Strategic Thinking

Technical Writing

UPLC

Education

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

Job description

The Small Molecule Analytical Research and Development 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 shelf-life 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 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

Applicants must hold one one of:

• 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.
• Batchelor'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

#AR&D

Required Skills

• Adaptability
• Analytical Method Development
• Assay Development
• Bioanalytical Analysis
• Biochemical Assays
• Cell-Based Assays
• Chromatographic Techniques
• GMP Environments
• Innovative Thinking
• Nuclear Magnetic Resonance (NMR) Analysis
• Process Analytical Technology (PAT)
• Strategic Thinking
• Technical Writing
• Ultra Performance Liquid Chromatography (UPLC)

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.

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

EEOC GINA Supplement

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 i