Analytical Scientist - HPLC Method Validation

BioPhase Solutions

Analytical Scientist Method Validation

Job Description:

We have a great position open for a Chemist to work for a very exciting company that is looking to expand its Analytical Group. In this role, you will validate HPLC analytical test methods for drug products, intermediates, and excipients under limited guidance from the supervisor. There will be some HPLC method development.

Functions include:

Write and review documents such as validation protocols, technical reports, and Standard Operating Procedures
Provide technical support and training to AD and QC personnel
Write and maintain applicable method, equipment, and procedural SOPs
Write development and other technical reports
Review laboratory notebooks
Review technical documents (Material Specifications, SOPs, and technical)
Characterize reference standards
Identify, assess, and implement new instrumentation and analytical technologies
Provide analytical support to QC, Process Development, and Manufacturing as needed
Assist others including management during Regulatory inspections and internal audits
Train QC Analysts and new personnel
Maintain up-to-date knowledge on applicable developments in chromatography
Maintain up-to-date training in cGMPs
Maintain up-to-date knowledge of USP, Ph.Eur, and ICH

For more information please contact Justin Freyre with Biophase at justin@biophaseinc.com

This position requires a minimum of a BS in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 4 years of GMP laboratory experience. Hands-on experience with analytical HPLC, GC, UV, and other related technologies is required. Candidates must have strong writing, documentation and mathematical skills as well as familiarity with USP wet chemistry procedures and basic laboratory instrumentation. You must be able to follow cGMP guidelines and be familiar with USP and ICH guidelines. We are seeking an independent worker.

Keywords: chemistry, chemist, HPLC, GC, LCMS, LC/MS, biology, biologist, microbiologist, cell culture, ELISA, PCR, molecular biology, scientist, cloning, DNA, tissue culture, histology, cell based assay, QC, QA, GMP, tech, technician, vivarium, animal, pharmacology, PK, submissions, NDA, mammalian, Western blot, drug discovery, organic, synthesis, environmental monitoring, LAL, endotoxin testing, medical, assistant, Lab, glassware, solution, prep, bacterial, aseptic