Manager, Microbiology-Product Testing in Wilmington OH. Manage product testing group responsible for completing bioburden, endotoxin, sterility, and particulate testing for raw materials and drug products, including oversee operation of lab; monitor test schedule, data, & work quality; project staffing & equipment needs; identify areas of process improvement; establish group/individual goals and manage performance; perform annual performance appraisals; review/approve SOPS, studies, and investigation reports; ensure methods meet regulatory requirements; conduct trouble-shooting & OOS investigations; assist in solving microbiology-related deviations/issues; represent QC during regulatory inspections; oversee up to 15 staff. Reqs: Master's in microbiology, pharmaceutical science or closely related field and 10 yrs exp in microbiology lab in pharmaceutical/biotech industry (in alternative, will accept Bach. & 12 yrs), including 8 yrs microbiology lab management exp, 7 yrs leading QC product testing group in pharmaceutical industry;5 yrs in facility start up and qualification of aseptic fill lines; 5 yrs with sterility, bioburden, endotoxin, particulate, disinfectant qualification, preservative challenge test, mycoplasma, In-use study, Hold time study and CCI testing; (exp. can be gained concurrently). Knowledge of Quality Risk Management, Lean Operation and management, parenteral/solid oral dosage manufacturing, representing QC Microbiology before regulatory agencies and third party audits, cGMP, USP, FDA, and international compendial requirements. By resume to daniel.bergmann@alkermes.com.

Experience Level:
Mid-Senior Level

(function () {
'use strict';
socialShare.init();
})();