Quality Assurance Batch Record Reviewer/Contract - South San Francisco, CA | Biospace
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Quality Assurance Batch Record Reviewer/Contract

NGM Biopharmaceuticals, Inc.

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Location:
South San Francisco, CA
Posted Date:
6/23/2017
Position Type:
Full time
Job Code:
QAPS11316
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
QA, Quality, Quality Assurance,

Job Description


NGM Biopharmaceuticals, Inc. is a private, maturing biotech start-up dedicated to discovering the next generation medicines to treat grave diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates, and other distinguished researchers to form a company where innovation and cutting edge science will provide the foundation for a robust drug discovery engine. In 2015, we established a broad collaboration with Merck that will provide us with the resources and flexibility to pursue our ambitious research and development goals. This partnership is a strong validation for NGM as a biologics discovery engine that will generate transformational medicines for unmet medical needs.

NGM is currently offering a unique opportunity for a highly motivated individual to join our Quality Assurance Team as a contractor. This position will principally provide Quality support for the manufacture of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) to ensure that NGM Bio’s drugs are in compliance with Current Good Manufacturing Practices (cGMP) and are of the appropriate quality for their intended use. This person will serve as a liaison of quality related issues with NGM Bio’s Chemistry, Manufacturing and Control (CMC) Team.  The position is planned to start at 3-days/week and could be changed based on the work needs.

Responsibilities:

Support NGM Bio QA through the execution of all aspect of GMP quality. The position will requires a strong QA biologic CMC background and the ability to interact regularly with operations management and QA at both the CMOs and NGM Bio on matters concerning the review of executed batch records, product quality and CMO cGMP compliance. The activities may include:
•   Review of executed batch records, Certificates of Analysis and other documents to enable drug substance and final drug product release certifying batches as GMP compliant.
•   Assisting with the internal NGM Bio Quality Systems including document control activities.
•   Support documentation of the training of NGM Bio’s GXP employees and assure compliance.
•   Interacting with CMO QA, QC and Operations to develop a single team partnership environment.
•   Investigating (with CMO), reviewing and communicating deviations at CMOs to NGM Bio’s QA and CMC Teams and functional management. Obtaining and communicating NGM Bio’s deviation investigation requirements to CMOs and working with CMOs to investigate deviations until resolved.
•   Review equipment qualification protocols and reports and process validations as appropriate.
•   Working with the CMC team, review of QC data related to product release and stability activities.
•   Assisting with governmental regulatory agency inspections of NGM Bio and NGM Bio’s contractors.
•   Work with the CMC and Clinical teams, providing assistance as required, to ensure IMPs arrive at clinical sites in time to support aggressive timelines.

Requirements


•   BA in Chemistry, Biology, Bioengineering or related field
•   Minimum 3 years’ experience working in QA in a biopharmaceutical company.

NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options and a comprehensive benefits package.