Analytical Research & Development Scientist

Veranova L P•West Deptford Township, NJ

About The Position

Analytical Scientist: THE ANALYTICAL SCIENTIST IS RESPONSIBLE FOR THE IMPLEMENTATION OF ANALYTICAL PROCEDURES IN SUPPORT OF SAMPLE TESTING, METHOD DEVELOPMENT, METHOD QUALIFICATION/TRANSFER/VALIDATION, GMP/N-GMP PRODUCTION, REFERENCE MATERIAL PROGRAM, METROLOGY, AND STABILITY TESTING WITH PARTICULAR EMPHASIS ON LC, GC, LC-MS, GC-MS, NM, XRD AND ICP-MS METHODS FOR ACTIVE PHARMACEUTICAL INGREDIENTS (APIS) FOR SMALL MOLECULES AND PEPTIDES. THE ANALYTICAL SCIENTIST IS EXPECTED TO SUPPORT THE FUNCTIONS INCLUDE ANALYTICAL METHOD DEVELOPMENT, QUALIFICATION, METHOD TRANSFER AND VALIDATIONS AND SAMPLE ANALYSIS BY A VARIETY OF ANALYTICAL TECHNIQUES WITH RESPECT TO POTENT COMPOUNDS.

Requirements

PhD in Analytical chemistry or equivalent with 0- 4 years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
Experience with common analytical techniques such as: HPLC, GC, LCMS, GCMS, NMR, UV, KF, FTIR, XRPD and ICPMS.
Minimum of 0 to 4 years’ experience in method development and validation for small molecules/Peptides Active Pharmaceutical Ingredients (APIs).
Experience in a cGMP environment
Ability to write clear and concise technical reports.
Good understanding of Microsoft Office and statistical software.
Demonstrates ability to exercise good judgment and make decisions quickly.
Good written and verbal communication skills.
Ability to work independently and in a team environment.

Responsibilities

Perform method development activities, drafts method qualification/validation protocols for analytical procedures and for instrument qualifications.
Transfers, validates and qualifies analytical methods.
Performs sample analysis, interprets results, and reviews data packages.
Performs testing for qualification and re-qualification of reference materials.
Documents all analyses per SOPs.
Prepares high quality written documentation (protocols, notebooks, CoTs, summary reports, SOPs, and analytical reports).
Troubleshoot analytical instrumentation.
Instrument software qualification and vendor communication.
Communicates effectively in verbal and written form on research results and plans.
Volunteers to assist with tasks not directly related to a specific project.
Demonstrates initiative in handling responsibilities.
Contributes to the technical growth of the department and company.
Participates in self-development activities.
To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.