This role is based in Boston with a hybrid schedule (three days onsite per week) however may be remote with monthly office visits for team interactions. Responsibilities Review of Drug Substance and Drug Product CDMO manufacturing records. Review Quality Events (i.e. deviations, OOS) relating to the manufacturing of clinical material lots. Provide cGMP disposition of Drug substance / Drug product. Qualifications Bachelor's degree in life sciences or related industry experience. 3+ years of GMP Quality experience in biotech/pharma. Experience with external manufacturing and supplier Quality oversight with a CMDO Strong knowledge of GMP regulations (FDA, EMA, ICH). Experience with batch review and disposition. Experience with biologics manufacturing processes Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders. Detail-oriented mindset with a proactive approach to problem-solving and decision-making. #J-18808-Ljbffr
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