Sr. Scientist, Analytical R&D

Merck; Rahway (NJ); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

Merck in Rahway, NJ seeks a Senior Scientist to advance analytical methodologies for early to late phase programs, covering drug substances, dosage forms, and formats.

You will contribute to GMP-compliant method development, release testing, and data analysis, with opportunities to lead cross-functional teams and support regulatory submissions to enable clinical trials.

Qualifikationen

• Develop analytical methodologies for small molecule drugs.
• Experience supporting regulatory submissions.
• Demonstrated leadership on technology and analytics teams.

Aufgaben

• 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 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

Jobbeschreibung

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.

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