QC Protein Analyst Xcellerex

Job Type: Regular, Exempt
Reports to: QC Manager
Summary
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.
? Understanding of current Good Manufacturing Practices.
? 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 expertise

Location:	170 Locke Drive Marlborough, MA 01752 United States