Job Information
Job Description
SUMMARY OF POSITION
The Scientist is primarily responsible to perform the following tasks independently.
Related Compounds method development for peptides.
SEC-HPLC method development for analysis of aggregates in peptides.
LCMS sequencing of peptides.
Amino acid profiling/quantitation for peptides.
The following requirements are desirable but not must:
Performs various analytical testing, including dissolution, HPLC and GC testing following established testing procedures for raw materials, finished products, and/or stability samples.
Performs method validation independently, including protocol and report writing and reviewing.
Performs method development, including HPLC, GC, Dissolution, UV, XRPD, SEC, PSD, Viscosity, etc., as well as methods using more advanced analytical technique for small molecules.
Identifies critical method attributes. Identifies, develops, and justifies methodology and specifications supporting API and finished products under development.
ORGANIZATION STRUCTURE
The Analytical R&D Scientist reports to the Research Fellow/Principal Scientist, Analytical R&D.
RESPONSIBILITIES
Hands-on experience on various method development for peptide analysis, including related compounds methods, is must.
Hands-on experience on method development, improvement, and validation, including but not limited to HPLC, GC, Dissolution, LC-MS, GC-MS, XRPD, PSD, Viscosity, SEC, etc., as well as compendial tests. instrument trouble shooting
Be a skilled experimentalist in various analytical method development to support the needs of product development for large molecule drugs.
Independently performs unknown impurity identification study and material characterization study.
Prioritizes activities to provide timely analytical support to product development. Anticipates analytical issues early in the R&D development process and provide long term planning for analytical method development and improvement.
Performs quantitative and qualitative LC-MS analysis, and IVIVR dissolution method development.
Reviews data, design and execution of experiments, and interprets results to define solutions, identify new methods to enhance the analytical capacity.
Demonstrates comprehensive understanding and use of scientific principles and professional practices to solve a wide range of complex problems in creative and practical ways.
Participates in design and review protocol outlines, reviews results and finalizes reports.
Delivers and communicates accurate results to project teams, provides intellectual input, and contributes to decision making.
QUALIFICATIONS
PhD, MS or BS in Chemistry, Biochemistry or related discipline with 4+ years (PhD) or 7+ years (MS), or 10+ years (BS) of experience in pharmaceutical industry or CROs.
Experience in analytical techniques including UV-Vis, RI, Fluorescence detection, HPLC, SEC, LC-MS, CE, CD spectroscopy, GC-MS, NMR, KF, FTIR, DSC etc. and advanced analytical technique.
Must have recent working experience in analytical method development for large molecules including peptides.
Good understanding of regulatory requirements: ICH, USP/EP/JP etc.
Ability to work independently and manage projects in a timely manner.
Understanding of cGXP requirements preferred.
Strong organization, communication and interpersonal skills.
EOE/M/F/Vet/Disability
Company Information
Our passionate team is committed to continue to grow our business around the world and to becoming a top 5 global generic pharmaceuticals player. North America is our largest market with over 60 pending ANDA filings. Other markets include Romania, Hungary, Korea, Taiwan, Bulgaria, Japan, China and Russia.
Building B
Pine Brook, NJ 07058