Maykoe R.
Senior Biotech Quality Control Supervisor
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Mike A. is an experienced molecular biologist and microbiologist with over a decade in R&D and quality control across the biotech and CDMO sectors. Serving as QC Micro Supervisor at Charles River Laboratories, he managed microbiology operations within a cGMP environment, directing staff training, performance oversight, and client-focused drug-product release support. He has extensive hands-on expertise in molecular assays such as qPCR, PCR, and CRISPR/Cas9, and has administered LIMS for laboratory data. At Amycel Biotechnical Research Lab, Mike A. supervised teams developing mushroom hybrids, conducting genomics projects, and implementing bioinformatics analyses and sterile culturing techniques. His detailed experience encompasses Trackwise system use for deviations, CAPAs, and change control, as well as authorship of SOPs and validation reports, directly supporting regulated therapeutics and commercial agriculture R&D.
Experience
QC Micro Supervisor / QC Micro Specialist
Charles River Laboratories · 2023 — 2026Managed microbiology operations within a cGMP CDMO, overseeing staff scheduling, training, and performance evaluation. Conducted data reviews and lot dispositions for drug-product releases, ensuring coordination of cross-functional release decisions with clients. Supervised environmental monitoring and sterility testing workflows, including BacT/Alert, endotoxin, bioburden, and MycoSEQ qPCR. Administered LIMS for labware and test data while reviewing and approving release testing. Handled quality investigations using Salesforce Trackwise, involving deviations, CAPAs, change controls, invalids, and OOS, as well as authoring and revising SOPs, test methods, EMPQs, and qualification/validation reports. Acted as the client-facing point of contact for timely communication of testing results.Research Scientist Supervisor
Amycel Biotechnical Research Lab · 2014 — 2023Supervised a team of microbiology and research technicians, managing lab operations, supply procurement, and purchase orders. Led projects focused on breeding and genomics to develop commercial mushroom hybrids, including the design and execution of commercial trials and phenotyping. Conducted molecular genotyping and expression assays utilizing qPCR and PCR, as well as marker/primer design, MAS, trait mapping, and bioinformatics analyses. Developed genome-editing workflows involving CRISPR/Cas9 and Gibson assembly for gene replacement. Ensured maintenance of sterile culturing practices for fungi and microbes, along with management of LN2 cryostorage for strains.Materials Analyst
Threshold Enterprises · 2013 — 2014Executed raw-material testing and conducted chemical and physical identifications. Performed bacterial identification assays while providing customer service support.
Skills & Expertise
Education
- B.S., Molecular, Cell, and Developmental BiologyUniversity of California, Santa Cruz · — — 2013