Associate Scientist: Injectable: Product Development
Pune_RD, MH, IN
Job Description
1) Perform characterization of peptide, iron colloid, nucleic acids-based or other injectable drug products primarily using Nuclear Magnetic Resonance (NMR) spectroscopy, and other methods if required, following good laboratory practices (GLP) for regulatory submissions. Extensive experience (3+ years) in independently handling NMR spectrometers is required.
2) Perform NMR data acquisition, processing, interpretation and report preparation for different NMR experiments, including 1D (1H), 2D (HSQC, HMQC), DOSY, etc. Perform statistical calculations (PCA, Mahalanobis Distance, CCSD, etc.) as per regulatory expectations.
3) Preparation, review and documentation (SOP, STP, Test Reports, etc.) of analytical methods, manage deviations and incidences as per established procedures. Candidates should have a good understanding of literature, implement new research methods and ideas to overcome challenges.
4) Undertake routine maintenance, calibration & other necessary activities for upkeep of the NMR instruments – coordinating with service engineer, inventory and consumables management, etc. Manage sample collection, storage, and disposal. Maintain the NMR laboratory in compliance with GLP requirements.
Work Experience
5-8 years (M.Sc./ M.Tech./M.Pharm)
or NIL (PhD)
Education
Competencies