Job Listing: ANALYTICAL SCIENTIST, QUALITY CONTROL

Description: In this position you will be responsible for review of technical documents written in support of regulatory submissions including the chemistry manufacturing controls section of INDs and NDAs.
Responsibilities:
Key participant in the review of technical documents written in support of regulatory submissions.
Trending test results and performing investigations.
Makes recommendations for major changes in procedures for SOPs, protocols and reports pertaining to QC project functions and GMP compliance in light of technical progress and historical results when necessary.
Good record keeping, writing standard operating procedures and reports.
Regularly reviews the status of assigned projects and provides recommendations.
Provides recommendations for resource needs of assigned QC projects.
Represents Quality Control project interests during strategic planning and is the primary point person for designated cross functional project meetings.

Skills: This position requires a Ph.D in Analytical Chemistry.
5+ years of applicable analytical chemistry experience in a GMP pharmaceutical/biotechnology environment. Demonstrated experience in method development and validation and release testing of drug substance and drug product (small molecules), ICH stability studies, reference standard qualification, cleaning validation. Knowledge of lab operations and regulatory requirements of the (CMC) section of INDs and/or NDAs is required. Strong oral and written communication skills and the ability to work both independently and as part of a team are required.

Demonstrated experience with lab instrumentation, including HPLC, GC, Karl Fischer, IR spectrophotometry, LC/MS, GC/MS, NMR, dissolution, DSC, particle size, PXRD. Demonstrated experience with cleaning verification is an asset. Review of technical documents and experience with contract service providers is a definite asset. Formal cGMP training including knowledge of FDA and ICH guidelines.
Our client offers an excellent benefits package and a very competitive salary!

For additional information, please contact David Schwarzenbek at dschwarz@Aerotek.com or 619-278-3026

Required Skills for ANALYTICAL SCIENTIST, QUALITY CONTROL Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.