Process\Analytical Scientist Job Listing at Genzyme Corporation in Framingham, MA

Biotechnology, Pharmaceutical

Process/Analytical Scientist-31379

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent ground breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Job Responsibilities/Department Description:

The Process/Analytics Scientist will join Process Analytics (PA) department, Commercial Process Development (CPD), and is responsible for assay development, qualification, and validation, and is experienced in assay transfer. The incumbent will design and execute studies for protein characterizations, and actively participate in sample analysis and analytic support for the late stage product development activities in CPD. This individual must have in depth understanding in protein characterization, assay development, and hands on experience in common protein analytical techniques.

Major responsibilities of this individual will include:
Design and execute study protocols for protein therapeutics characterization
Develop, qualify, and validate assays for biochemical/biophysical characterization with a focus on speed and throughput
Transfer the release or characterization assays across the different functions
Provide analytical support to product development activities within CPD departments
Conduct data analysis, interpret and communicate assay results, and write study reports
Coordinate the efforts among groups for sample analysis and analytic supports
Attend development and scientific meetings to remain current with technology and regulatory guidelines
Mentoring and coaching other junior member in the group

Qualifications
Basic Qualifications:

Ph.D. or experienced M.S in life science related fields, with 2-5 years (PhD) or 6+ years (MS) working experience, preferable in pharmaceutical or biotech industry
Solid understanding in protein assay development, assay qualification, assay validation, and assay transfer.
Extensive previous hands-on experience in protein characterizations with common analytical techniques, including SDS-PAGE, enzyme activity assay, IEF, HPLC, ELISA, and glycan characterizations

Preferred Qualifications:

Previous experience in working with high throughput assay platform, such as Tecan and Caliper, will be highly desired
Excellent writing and communication skills, and experienced in documentation and writing study report
Working knowledge in protein therapeutic development process and relevant regulatory guidelines
Previous experience working in GLP or GMP environment, and able to complete project under time pressure and/or resource restrain
A good team player who can lead or contribute to the team efforts, and willing to mentor and coach other junior team members

Job : Manufacturing Development
Primary Location : United States-Massachusetts-Framingham

Job Posting : Oct 24, 2012

Shift : Day Job
Job Type : Regular
Employee Status : Regular