Sr AD/QC Analyst

Our client is dedicated to the advancement of technology for improving the speed and quality of process development. Located in Marlborough, Ma our current need is a direct hire opening for an AD/QC Analyst.
In this hands-on position, the Analyst will perform a wide variety of method development and GMP Quality Control testing including in-process, release and stability testing. The Analyst will participate in set-up of the QC laboratory including the purchase and installation of additional equipment, transfer and validation of assays, staffing and training, qualification of reagents and creation of cGMP compliant documentation.

Essential Functions
Perform method transfer and method development and qualification for analytical methods destined for GMP use.
Perform GMP Quality Control testing for multiple projects. Coordinate outsourced testing.
Perform data reviews, prepare reports and quality documents. Write SOPs.
Manage and perform tasks critical for maintaining compliance with the applicable regulatory requirements.

Knowledge, skills and abilities
Experience in analysis of proteins with demonstrated knowledge of modern protein analytical techniques (HPLC, ELISA, CE, gel electrophoresis, mass spectrometry).
Experience in quality control and method validation in the pharmaceutical industry.
Proven team player with well-developed interpersonal and mentoring skills.
Excellent organizational skills, communication skills, including written documentation skills and presentation skills.

Minimum qualifications
B.S. in biomedical science or chemistry.
At least five years experience in Analytical Development and Quality Control for protein drugs.
Ability to work in GMP and non-GMP environments
Broad range of protein chemistry expertiseKelly Services is an Equal Opportunity EmployerContact?Information?:.One Exeter Place, 10th Floor
Boston?MA?02116