CMC team and work closely with the Operations organization. This role will thrive in a highly collaborative matrix team...
registration of products worldwide, representing GDPU and M&S on Global Project Teams and CMC sub-teams. Direct innovation...
according to the project scope working with the CMC Project Leader. Acts as the primary QC member during the project phase...
, regulatory, CMC, operational, and competitive factors that influence program risk and probability of success. Comfort using...
, process validation readiness, commercial readiness, or digital manufacturing systems such as MES. CMC development, biologics...
clearance. Preferred Qualifications: Certification in Configuration Management (e.g., CMII-P, CMC). Ability to create...
analytical CMC content for INDs, IMPDs, NDAs, amendments, annual reports, briefing documents, and health-authority responses... Analytical Development on CMC program teams and communicate risks, recommendations, timelines, and resource needs to internal...
Development/PD, quality, CMC and design future-state AI-enabled processes and translate into AI-ready problem definitions;Drive...
participant on multidisciplinary CMC project teams that support bioproduct process and product development activities...
clinical, nonclinical, CMC development, and regulatory interactions, submissions/reviews globally Highly motivated, proactive...