United States of America
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This position will coordinate Process Validation (PV) study samples, documentation and results. It may also support analytical testing by executing and documenting methods per test procedure returning quality data.
Process Validation in Analytical Operations (PVAO) coordinates analytical testing in support of PV studies, technology transfers, and investigations for Stage D and post-approval molecules across the Roche network. s manage sample coordination, data and documentation in a compliant environment tracking metrics and maintaining business systems.
PVAO is a part Analytical Operations (AO) in Pharma Technical Development (PTD). AO provides analytical support for process development enabling informed and timely process decisions. AO develops and runs a wide variety of technologies including lab automation, ELISAs, UHPLC and mass spectrometry supporting PTD from Stage A through D and E.
Specific job duties/responsibilities include: handling of biological and chemical reagents, following study protocols, preparing samples, scheduling testing, communicating study status to stakeholders, overseeing the quality and compliance of the work, executing assays per test procedure, assay and lab maintenance, presenting in formal settings, and writing summary reports.
The individual will be required to work independently as well as in a team environment within AO and with analytical groups, technical teams, quality, BioProcess groups, and external contacts for contract manufacturing facilities or satellite Genentech facilities. They will communicate effectively with all levels of the organization. The individual will be expected to follow applicable procedures, quality standards and policies, and comply with industry guidelines.
Bachelor's degree in Biological Sciences field with a minimum of 1-2 years of laboratory experience in biotechnology area. Requires initiative, attention to detail and a desire to deliver high quality work. Must be able to manage multiple projects simultaneously and accommodate shifting priorities and timelines. Must willing to support analytical testing.
Additional requirements include: strong written and verbal communication, good organization, multi-tasking and problem-solving skills, familiarity and knowledge of cGMP’s and compliance. Knowledge of analytical methodologies (ELISAs, UHPLC, or others) is also desirable.
Proficiency in Microsoft Word and Excel is necessary. Experience with Electronic Lab Notebooks (ELN), LIMS, databases and programming, experience running analytical assays such as ELISA and HPLC, and project management experience are pluses.
Who We Are
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.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.
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