Scientist, Analytical R&D (2nd shift operations: Cleaning Verification)

MSD•Rahway, NJ

1d•Onsite

About The Position

The Pharmaceutical Analytical Sciences group has an opening for a second shift 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 Scientist, you will be part of a team of scientists working on cross-functional scientific teams to enable development of novel small molecule, peptide, and oligonucleotide drug development through laboratory-based analytical support including cleaning verification analysis of our cGMP manufacturing operations. This role is fully onsite during 2nd shift operations (3pm – 11:30pm).

Requirements

Minimum 3 years relevant industry experience for applicants with a Bachelor of Science degree, or 1 year of relevant industry experience for applicants with a Master of Science degree
Degree in Chemistry, Pharmaceutical Sciences, or other Life Sciences.
Excellent written and oral communication skills
Interpersonal skills
Work in a team environment with cross-functional interactions.

Nice To Haves

Hands-on experience in GMP Operations
Advanced chromatographic separation science
Method development/method validation.
Experience with Empower and lab investigations/deviations are a plus.

Responsibilities

Support execution of Good Manufacturing Practices (GMP) activities such cleaning verification, method development and method validation to support development of active pharmaceutical ingredients (APIs), pharmaceutical formulations, and manufacturing processes using both traditional and advanced analytical tools during second shift operations
Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA+ principles.
Troubleshoot any investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders and identify appropriate corrective and preventative actions.
Perform data entry, data review, and author analytical reports or data summaries.
Work collaboratively with internal stakeholders and partners such as Global Development Quality and Pharmaceutical Operations.
Support internal and external compliance audit activities.