Staff External Manufacturing Specialist (Drug Product)

Role: Senior technical expert overseeing clinical drug product filling operations at CMO sites, accountable for technology transfer, batch management, and GMP compliance. Responsibilities: lead end-to-end tech transfer, evaluate cleanroom design, approve critical documentation, mentor mid-level specialists, monitor active batches, investigate deviations, and ensure regulatory adherence for sterile filling and lyophilization processes. Requirements: Bachelor's or higher in Pharmaceutical Sciences, Chemistry, or related field; 10+ years' experience in pharmaceutical/biopharmaceutical sterile drug manufacturing, with hands-on GMP sterile filling expertise, tech transfer, and CMO oversight. Preferred: leadership in process validation, deviation investigations, and cross-functional collaboration skills. High-Value: expertise in aseptic filling, lyophilization, CCI, GMP compliance, regulatory documentation (IND, BLA), and international travel (~25%). Location: Rensselaer, NY; on-site with travel. The role emphasizes technical mentorship, active batch oversight, and ensuring product integrity in a GMP environment.