Associate, QC Microbiology/Environmental Monitoring (CONTRACT)
Manager: Manager, QC Microbiology
Department: 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. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today’s medicines can only treat symptoms. At Sangamo, we are passionate about transforming 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.
Sangamo Therapeutics is seeking a QC Associate that is focused on Sterility, Bioburden, Endotoxin testing with a primary focus on environmental monitoring. The position will execute environmental monitoring, personnel monitoring, utilities sampling, and perform in-process and release QC microbiology product testing, while adhering to cGMP and GLP guidelines. A 5 day per week work schedule, with at least one of the working days falling on a weekend (Sunday-Thursday or Tuesday-Saturday) is required.
- Work with QC microbiology team to sample/collect at-rest and in-use environmental samples from the manufacturing facility.
- Collect and test utilities samples (compressed gasses, water, steam, 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 in 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.
- 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 long periods of time with cleanroom gowning covering the whole body and head.
- 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 will be routinely required.
Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws
Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine & booster, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves.