Sr. Scientist, Small Molecule Analytical R&D (Onsite)

Job Description

Sr. Scientist, Small Molecule Analytical Research & Development

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 will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities, in no particular order and by no means complete, include:

Primary Responsibilities

• Drive solutions to development challenges for small molecules, peptides and oligonucleotide active pharmaceutical ingredients and pharmaceutical products through active collaboration with cross functional project teams and external vendors.

• Design scientific studies to inform the selection of early development and market formulation compositions and manufacturing processes using conventional and novel analytical technologies.

• Document the experiments in a detailed manner.

• Develop and implement analytical methods utilized for both development as well as methods for the re­lease and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) settings.

• Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/ worldwide marketing application (WMA) submissions as well as responding to agency questions.

• Collaborate closely with internal stakeholders and partners.

• Lead analytical activities on drug development within the pipeline as well as innovative technology teams defining the dosage forms and analytical characterization tools of the future.

• Present results of experiments and innovation efforts to teams and internal governance bodies.

• Be a leader within the external scientific community in professional organizations, conferences, and publications as well as analytical technology and regulatory sciences related focus groups and consortia.

Education Minimum Requirements

PhD degree (graduating on or before December 2025), 3 years experience with a MS degree, or 7 years experience with a BS degree in Chemistry, Pharmaceutical Sciences, other Life Sciences, or equivalent with analytical measurement and characterization 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 as well as interpersonal skills.

Preferred Experience and Skills

Though not required, the ideal applicant would have hands-on experience in advanced chromatographic separation science, spectroscopy, and other analytical techniques. Experience with data science, dissolution, and LCMS (liquid chromatography- mass spectrometry) are also a plus.

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Required Skills:

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

Preferred Skills:

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