Associate, Quality Control – Microbiology

Manager: Senior Manager Quality Control-Microbiology

Department: Quality, Technical Operations

Location: Brisbane, CA

Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate about developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion.  Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
 

We are seeking top talent to join our mission. Let’s build a better future together.

JOB SUMMARY:   

Sangamo Therapeutics is seeking an Associate to join our Quality Control – Microbiology team at our Brisbane manufacturing and testing facility. The QC-Microbiology Associate will execute environmental monitoring, personnel monitoring, utilities sampling and perform in-process and release QC micro product testing while adhering to cGMP and GLP guidelines.

ESSENTIAL FUNCTIONS: 

• Work with Senior QC microbiology personnel to sample/collect at-rest and in-use environmental samples from the manufacturing facility.
• Collect and test utilities samples (compressed gasses, water, etc.)
• Perform personnel monitoring on manufacturing personnel working in the Grade B manufacturing space.
• Test in-process and product release samples for bioburden, sterility, mycoplasma, adventitious agents, and endotoxin - adhering to all SOPs, test methods and agency guidelines.
• Perform growth promotion/media qualification and gram staining.
• Perform routine cleaning, stocking, and organization of laboratory areas.
• Peer review QC microbiology data.
• Assist in data trending and summarization.
• Assist with the drafting and review of QC-microbiology documents (SOPs, Protocols, Reports, etc).
• Assist QC microbiology management in the execution of investigations: OOS/OOT/MDD, invalid test etc.
• Support Sangamo Manufacturing and Quality Assurance groups executing aseptic media fills and media simulations.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Possess a BS in Microbiology, Biology, Virology or related field with a concentration in Microbiology.
• Have 0-2 years of Quality Control-microbiology experience in the biopharma, cosmetics, nutraceutical/supplement, or medical device fields.  QC microbiology experience in the gene and cell therapy fields is a plus.  
• Understand current GMPs with a familiarity of ICH, FDA, USP, PDA, and EMA (Ph Eur) guidelines as applicable to Microbiology quality control testing and facilities control.
• Have experience with Endotoxin, Bioburden, Sterility, Mycoplasma and adventitious agents testing. Knowledge and experience with current compendial and rapid testing methods is desired.
• Possess statistical analysis and data evaluation skills.

OTHER QUALIFICATIONS:

• Be able to operate in a fast-paced start-up environment handling multiple product lines and manufacturing operations.
• Pass gown qualification, and work for extended periods of time in clean room environments (Grade A-Grade D, and CNC space).
• Lift up to 30 lbs and work on your feet for periods up to six hours.
• Be able to work in a laboratory environment wearing appropriate PPE.
• Have excellent communication skills, both written and verbal.
• Be detail oriented.
• Possess strong interpersonal and team player skills.
• Have flexibility in their work schedule: early, late, weekend and overtime hours may be required.

Sangamo is an equal opportunity employer

The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned.

The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.

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