South San Francisco
California, United States of America
We are seeking an Engineer for our new, state-of-the-art high containment Drug Product manufacturing facility in the Small Molecule Pharmaceutical Sciences (SMPS), Genentech Research and Early Development (gRED). SMPS is responsible for the early pharmaceutical development (Ph I and II) of gRED small molecule drug candidates. The primary responsibilities for this position include:
Support Facility Manager to Partner with the project manager, facilities services, EHS, quality, and equipment system owners to drive forward a commissioning strategy for new equipment and provide user representation during commissioning/qualification activities to ensure all GMP equipment in the facility is installed and maintained in a validated state. Responsible for daily activities in GMP Suites and associated non-GMP solid development labs in Small Molecule Pharmaceutics (SMP) Department. This includes materials management, project scheduling, safety procedures, training reports, and equipment/facility maintenance and cleanliness.
An individual in this position should be familiar with the safety and cGMP practices, and is able to work closely with project formulators to facilitate/support manufacturing of GMP drug product for PhI/PhII clinical programs.
Who You Are
Relevant engineering and science BS/MS/PhD degree with not less than 5 years experience in small molecule pharmaceutical manufacturing operations.
In addition to basic qualifications, a successful candidate must have experience working in GMP environment and is proficient in preparation of GMP related documentations, including SOPs, batch records, and change records. The individual should have experience in operating small molecule unit operation equipment, including roller compaction, high shear wet granulation, milling, blending, tableting, and film coating.
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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