, and regulatory compliance. This role offers opportunities to work with varied product types (small molecules, biologics, vaccines... knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F). Direct...
-active biologics. Develop strategic insights on emerging competitors, clinical data, partnering activity, and market... for or interviewing for this position, please direct your inquiries to Human Resources, at Notice to Recruiters/Staffing Agencies...
Catalent’s Core Biologics segment is a rapidly growing business within Catalent Pharma Solutions, dedicated to delivering..., world-class manufacturing expertise, and integrated services across the Catalent network, Core Biologics is positioned...
Job Title: Biologics Process Development Engineer – Purification & Technology Transfer - (JP15447) Location: Thousand... be required 3 Key Consulting is hiring a Biologics Process Development Engineer – Purification & Technology Transfer...
for oncology and infusion patients at Simon Cancer Center at University Hospital. Working under the direct supervision... chemotherapy, biologics, and supportive care infusions, in compliance with USP 797 , 800 , and IU Health policies. * Perform...
therapy, or biologics manufacturing, including late-stage and launch products;Direct experience in a clinical cell therapy... biologics or cell therapy manufacturing experience with hands-on work in solution preparation, cell expansion/culture...
ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone... therapeutics, with direct impact on lead optimization and pipeline programs. You will build predictive and generative models...
products, facilities, and computer systems, aligned with business objectives and evolving regulatory requirements. Direct.... Extensive experience in the pharmaceutical and biologics industry required. Experience in performing risk management exercises...
Management, Supplier Quality and audit readiness. The incumbent will coach and develop their Direct Reports supporting the site... Six Sigma or Lean certification Experience in sterile manufacturing or biologics Reason to join US Much more than...
quality policies and approaches and coordinate implementation of new or changes procedures. Direct and independently perform... regulatory and accreditation inspections, including preparation and follow up activities. Direct and independently monitor...