Date: 12/17/13

QC Associate Scientist
Job ID: 00427084 Job Function
Quality Control

Schedule
Full-time

Location
United StatesUnited States

Job type
Regular Employee

Job Level Company/Division

Pharmaceutical Experienced

Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading researchfocused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to dtevelop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position
The Analytical Chemistry group in the Method Management and Technology (MMTech) Function within Genentechs Corporate Quality Organization provides technical and scientific support to the Roche/Genentech Global Quality Control Network for the commercial biotech product portfolio. We are looking for an experienced Senior Associate or Associate Scientist to take a leadership role in troubleshooting, transferring and validating analytical chemistry methods (e.g. HPLC, CE, UV) used for quality control purposes for commercial biotech products. MAIN PURPOSE OF THE POSITION Develop and execute plans for the development, validation, implementation and maintenance of QC test methods for marketed biologic products following cGMP regulations, regulatory guidelines and global quality standards. Support method transfers, investigations and CAPAs across the global QC network (including CMOs and partners). Troubleshoot and re-optimize QC methods as needed for marketed Roche/Genentech biotech products. Support regulatory submission and inspections through authorship of CMC subsections, responses to questions and direct interactions. JOB DUTIES/RESPONSIBILITIES

 Serve as analytical technical lead/representative (biotech products) on cross-functional and multi-site project teams. Ensure on-time delivery of controlled documents, reports and method validation packages to support project timelines. Troubleshoot and direct the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships. Perform assigned tasks and work to achieve company goals and department objectives. Support the development and administration of Quality Control and laboratory training materials. Train personnel on relevant QC methods and business processes.

Who You Are

Who You Are Candidate must have a BS or MS degree with 6-10 years of relevant experience in the pharmaceutical industry or a Ph.D. in Analytical Chemistry or other scientific field with at least 2 years of relevant industry experience. Candidate must also have knowledge and experience in using, troubleshooting and validating QC methods relevant to biological products. Experience with full ICH validation of methods intended for commercial use is highly desired. Strong knowledge of cGMPs and experience working in a QC lab is necessary. Strong communication (written and verbal) skills are a must. Strong planning skills are highly desired. Ability to work effectively in a cross-functional team is required. Strong technical writing skills are highly desired. Some travel may be required.

Genentech is an Equal Opportunity Employer.