Summary
The Merck Small Molecule Analytical Research and Development group is seeking a dedicated Scientist to join our GMP operations team in Rahway, NJ. This role is ideal for a high-energy professional with a passion for exceptional science and a commitment to improving human health through innovative drug delivery. You will join a diverse team characterized by strong ethics and integrity, focusing specifically on the critical task of releasing clinical supplies for new and ongoing studies. This is a hands-on, lab-based position that offers the opportunity to work with advanced predictive analytical tools in a fast-paced, collaborative environment.
Responsibilities
- Execute Good Manufacturing Practices (GMP) activities, including release and stability testing for active pharmaceutical ingredients (APIs) and pharmaceutical formulations.
- Utilize advanced analytical techniques such as HPLC, UPLC, and Dissolution testing to support clinical supply development.
- Document all experimental procedures, results, and conclusions with high precision, adhering strictly to ALCOA principles and Good Documentation Practices (GDP).
- Troubleshoot and investigate technical challenges in the lab through active collaboration with cross-functional project teams and Quality stakeholders.
- Validate and implement robust analytical methods to ensure the integrity of clinical materials.
- Manage data integrity by performing accurate data entry, thorough data review, and authoring technical reports or data summaries.
- Collaborate effectively with colleagues in Process Chemistry, Pharmaceutical Operations, and Global Development Quality to meet project milestones.
- Maintain a high level of independence in lab operations while contributing to a cohesive team environment.
Education
- Bachelor of Science (B.S.) in Chemistry, Pharmaceutical Sciences, or a related Life Science field with 3–5 years of relevant industry experience.
- Master of Science (M.S.) in Chemistry, Pharmaceutical Sciences, or a related Life Science field with 2 years of relevant industry experience.
Experience
- Core Technical Skills: Hands-on experience with HPLC, UPLC, Dissolution testing, spectroscopy, and advanced chromatographic separations.
- Software Proficiency: Practical experience using Empower software for data acquisition and analysis.
- Regulatory Knowledge: Deep understanding of GMP operations, GDP, and ALCOA documentation standards.
- Analytical Breadth: Experience with LCMS and data science applications is highly preferred; experience with Gas Chromatography (GC) is a plus.
- Soft Skills: Proven ability to troubleshoot independently, high attention to detail, and excellent verbal and written communication skills.
- Stability: A consistent and stable job history within a GMP or pharmaceutical laboratory setting is required.
Additional Information
- Location: This is a 100% onsite, lab-based role located in Rahway, NJ.
- Position Type: Temporary assignment with the possibility of extension based on performance and business needs.
- Work Environment: Requires a team-oriented "hard worker" who is curious, independent, and capable of operating without constant hand-holding.
