Offers “Roche”

Expires soon Roche

Project Coordinator / Research Assistant – Process Validation Analytical Operations

  • Internship
  • San Francisco (City and County of San Francisco)
  • Design / Civil engineering / Industrial engineering

Job description



·  Job facts

Note:

·  This role may be filled at the Associate Project Coordinator or Project Coordinator level.
·  We are only considering San Francisco Bay Area candidates. No relocation support is available for this role.

RESPONSIBILITIES:

This is a hybrid project coordinator and lab analyst position. The position will coordinate Process Validation (PV) study samples, documentation and results and join the assay scheduling team in Analytical Operations (AO). It will also support analytical testing by executing and documenting methods per test procedure returning quality data and participating in lab maintenance.

Process Validation in Analytical Operations (PVAO) is a part of 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.

PVAO coordinates analytical testing in support of PV studies, technology transfers, and investigations for Stage D and post-approval molecules across the Roche network. Project Coordinators manage sample coordination, data and documentation in a compliant environment tracking metrics and maintaining business systems.

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.

REQUIREMENTS:

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 be willing to support analytical testing and project coordination.

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.

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Roche is an equal opportunity employer.
Business Services & Support, Business Services & Support > General Business Operations

·  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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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