Must have a PhD in Microbiology, Cell Biology or a closelyrelated scientific field and at least 6 years of pre or postdoctoral bioprocess development experience in the biopharma industry. In lieu will accept a MS in Cell Biology or closelyrelated scientific field and at least 10 years of bioprocess development experience in the biopharma industry.br br Experience, which may have been gained concurrently, must includebr 6 years of experience across upstream mammalian cell culture inoculum expansion, bioreactor design, perfusion cultures, environmental parameters, media formulations, centrifugation, depth filtration media, etc. and downstream column chromatography, viral inactivation, viral filtration, ultrafiltrationdiafiltration, drug substance formulation, buffer solutions, etc. platforms.br 4 years experience in writing and reviewing GMP documents SOPs, Protocols, reports, batch records, change control documents related to biologics drug substance manufacturing.br 4 years of experience in developing and scaling up microbial fermentation processes for manufacture of recombinant human therapeutic products. Must have experience in supporting microbial scale up to 30,000L scale fermentors.br 4 years of experience successfully leading a team of engineers in multiple commercial tech transfers and commercial support activities involving process unit operations and equipment for new technology introduction, data analysis, process characterization, scaleup, and manufacturability for commercial drug substances.br 4 years of experience working closely with manufacturing facilities, including contract drug manufacturer organization CDMO partners, to ensure that manufacturing processes can rapidly and effectively be established for the drug supply of clinical andor commercial materials and to ensure that manufactured biologic drug substance meets the global quality standards as well as FDA requirements.br 4 years of experience in the preparation and authorship of relevant regulatory submission documents preIND, IND, BLA, etc. to the FDA and subsequent auditsreviews. Must have experience as the key subject matter expert SME and primary author for the drug substance sections of global regulatory license applications BLA, MAA for biologic drugs.br br Qualified candidates for consideration will be able to demonstrate indepth applied knowledge and expertise in the following areasbr data analysis, commercial support, and continuous improvement implementation for manufacturing scales from 500L to 15,000L bioreactorsbr cGMP and cGMP documents SOPs, protocols, reports, batch records, change controlsbr LEAN manufacturing and continuous process improvementbr scaling up bench scale processes and tech transfer to internal and external clinical and commercial manufacturing sites globallybr br This is a telecommuting position working from home, may reside anywhere in the U.S.br br br Note to Section I.c., Recruitment Information The recruitment advertisements were posted for EQRx International, Inc.s headquarters office location in Cambridge, MA. An additional recruitment advertisement was also posted in a national newspaper USA Today, since the job opportunity is telecommuting position and the candidate may reside anywhere in the U.S.
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