Due to the company’s expansion, we seek an organized and motivated (Sr.) research associate with microbial operating experience. You will be responsible for maintaining the microbial/BSL-2 laboratory to support microbiological test needs and will support the manufacturing process with environmental monitoring. This individual must be organized, work well in a cross-functional team setting, and have excellent communication skills.
Education / Background
B.S. or M.S. in life science-related fields (Microbiology, Immunology, Oncology, Molecular Biology, Pharmacology, Chemistry, and Biochemistry)
Experience with microbial culture, sterility tests, and microbiological tests required.
Experience in performing environmental monitoring at GMP/GTP factory.
Experience in maintaining a microbial lab is a plus.
Experience establishing and maintaining GMP/GTP-compliant laboratories is a plus.
Responsibilities include, but are not limited to
Set up a GMP/GTP-compliant Microbial Testing Lab for supporting the manufacturing process and daily operation.
Perform microbial culture, growth promotion test, sterility tests, and microbiological tests with the requirement from pharmacopeia.
Perform environmental monitoring during the GMP production in compliance with PIC/S GMP requirements.
Work with the manufacturing team to perform cleanroom validation and monitoring in compliance with the requirements of PIC/S GMP.
Analytical method qualification/validation and test report writing.
Deviation record and investigation.
Maintenance of QC laboratory equipment, usage logs, and equipment troubleshooting.
Create, maintain, and update QC-related laboratory SOPs
Perform microbiological testing for raw materials, in-process control, and product release.
Position Requirements & Experience Relevant Skills & Experience:
5+ years of experience in a microbiology laboratory
Microbial Lab supervisor
Establishing and maintaining GMP/GTP-compliant laboratory is a plus.
Self-motivated, enthusiastic, and enjoys a fast-paced environment.
Experience developing and generating SOPs
Excellent oral and written communication skills.
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Acepodia is a clinical-stage biotechnology company developing NK and γδ T cell therapies using our patented ACC (Antibody Cell-Conjugation) technology platform. Using ACC technology, we arm immune cells with antibodies to target and eradicate cancer cells. Our mission is to develop safe, effective, and affordable cell therapies to fight and beat cancers.
Founded in 2017 in the birthplace of biotechnology, the San Francisco Bay Area, CA. Acepodia is venture capital and private equity backed and funded. Our platforms and products aim to address and overcome the major obstacles in cancer therapy: Ability to target low expression of tumor antigens to better prevent tumor escape; Trafficking of effector cells to tumor locations; Activate the immune system to attack cancer cells.
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