Genentech Work Values

Daily Duties at Genentech:

Investigate and close out DMS. Investigate and resolve all OOS and OOT results Investigate and resolve Temperature Excursions for Drug Substance and Drug Product Review and approve stability timepoint data Represent QC Stability in all CMC/PMT Meetings initiate and devise QC Stability Strategies Author PMP Packages, NDAs, BLAs, PAS and Type II variation submissions to the FDA and EMEA. Initiate and Maintain annual stability commitments Author stability sections of ARs and APRs Keep Current on and track Timelines Maintain Department in a state of Inspection Readiness. Maintain Department in compliance with cGMPs Generate stability Reports Develop and work on Data trending projects Author and review SOPs and SRs Work with Partners and CMOs to ensure that Quality Agreements are being followed and Stability Studies are being implemented correctly Create stability protocols and studies within LIMS for routine and non-routine studies.

What they like about Genentech:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

Quality Control, Stability, Analytical chemistry, Project management, Method Development, Method validation, management, Lead chemist, Sr QC Associate, Sr. QC Chemist, Audits, Compliance, research Associate, IND, NDA, PAS, BLA, Submissions, Chromatography, San Francisco, South San Francisco, Oakland, Seattle, Bothell, San Diego

Skills

Software Implementation, Leadership , Chemist, QC Associate, method development, method validation, IQ/OQ/PQ, Audits, CMOs, Quality Agreements, QC Stability, supervisorial, managerial, Director, cross training, submission writing, data review, trending, LIMS, chromatography, JMP Software, Kaleidograph, Chemstation, Chemsystem, Millenium, Excalibur, Trackwise, Novaweb, Novamanage, empower, PeakPro, POMS Lot Trace, presentations CMC-RAC CMC-ARC, ARs APRs, investigate OOS/OOT and CAPAs, method transfer, Represent my team at cross functional meetings

These are some of the questions we asked our climbers about their experiences with Genentech: