- Eisai, Inc (Exton, PA)
- …Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to cGMP , ICH, EMEA, and JP Guidelines as well as ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a scientific team… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title cGMP Operations and Clinical Projects Associate Job Profile Title Research Coordinator ... (GMP) guidance and Good Laboratory Practice (GLP) compliance. The cGMP Operations and Clinical Projects Associate will serve as a liaison across multiple… more
- Catalent Pharma Solutions (Malvern, PA)
- …services lead, this role serves as the CMTI lead client development projects , collaborates to prioritize work, communicates project status and effectively ... CMTI capabilities. Serve a focal point for client development projects , prioritizing work, communicating project status, and...policies. + Ensure adherence to CMTI Quality systems and cGMP standards. Manage project and client expectations… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …of one or more processes. This role can support both Commercial and Clinical Operations + Verifies and inspects incoming materials and works accordingly ... located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical … more
- Lilly (Philadelphia, PA)
- …and consumables required for the uninterrupted manufacturing of commercial and clinical radiopharmaceutical drug products across a worldwide network of cGMP ... the global supply chain, maintaining approved suppliers/products for global operations , demand/supply/capacity planning, sourcing, labeling, dispensing, inventory management, shipping,… more
- Kelly Services (Titusville, NJ)
- …quality oversight for pharmaceutical (or equivalent) production, including manufacturing operations , cGMP compliance, and non-conformance investigation. + ... integration of external manufacturing facilities. Support a variety of projects both internally and with external manufacturers. **Qualifications:** **Education:** +… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …record review and release. The position requires communication between the operations /production, project management, shipping and quality assurance groups to ... and Catalent employee.** **The Role:** + Independently manage assigned projects or support the Project Management (PM)...production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol Includes review… more
- Catalent Pharma Solutions (Malvern, PA)
- …employee.** **The Role** + Carry out all duties in line with the QA / cGMP / Safety standards at CMTI. Carry out the analytical testing activities of pharmaceutical ... compendial testing, etc. Support Management by communicating directly with clients regarding new projects , on-going projects , etc. + Able to evaluate data and… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …our ability to plan and execute the production of commercial and late-stage clinical products efficiently, timely, and with high quality. Scope of the role covers ... of the role will be CI of Commercial or clinical products. The role will provide coaching, direction and...year on year and developing a healthy pipeline of project for future years. The role will have no… more
- Kelly Services (King Of Prussia, PA)
- …years of experience in clinical research, clinical supply, or pharma operations . - Knowledge of ICH-GCP, cGMP , and clinical study regulatory ... DESCRIPTION:** The Senior CTS Packaging & Labeling Specialist will support the Clinical Trial Supplies (CTS) team in coordinating packaging and labeling activities… more
- BeOne Medicines (Pennington, NJ)
- …shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use. ... + Minimum of 2-5 years of experience in people management, knowledge of cGMP and Data Integrity Guidance utilized in a manufacturing operations environment.… more
- Eurofins (Philadelphia, PA)
- …discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you're looking for a rewarding career, a place to call ... all applicable quality systems and current cGMPs within the Quality Control Operations organization. They will support the departmental goals and contribute to… more
- Merck (Wilmington, DE)
- …on-time execution of commercialization activities of our pipeline products and routine clinical /commercial operations . This role will report into the AVP, ... **Job Description** The Technical Operations Director is accountable for the operation of.... The role plays a critical part in strategic project realization of the Wilmington Biotech facility, a new… more
- BeOne Medicines (Pennington, NJ)
- …on cost of goods reduction. + Scale-up through technology/process transfer to clinical and commercial manufacturing. + Ensure accurate and complete documentation of ... any scientific experimental plans, data and reports. + Uphold all cGMP standards for process qualification, deviation investigations and all related documentation. +… more
- Kelly Services (Malvern, PA)
- **QA Associate** Kelly(R) Science & Clinical is seeking **QA Associate** for **a contract to hire** position with a growing chemical manufacturing leader in ... driven studies for AET testing. + Provides written and verbal updates on projects and activities as required. + Troubleshoots equipment and methods. + Analyzes and… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …+ Leads communication between functional areas of the organization (ie. BD, Project Management, Operations , Quality, Finance, etc) to ensure on-time delivery ... Client Services, identifies and independently drives delivery of strategic process improvement projects on behalf of the global team and/or the business **.** **The… more
- J&J Family of Companies (Spring House, PA)
- …Quality Assurance specialists responsible for the quality oversight of supply chain operations supporting production of commercial and clinical drug substance in ... providing input on the site goals and objectives, prioritizing projects , and coordinating resource allocation to meet base business...audits. + Provide leadership and insight as on global project teams. + Other duties may be assigned as… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label… more
- System One (Lawrenceville, NJ)
- …assets and will collaborate extensively with cross-functional stakeholders including IT, Project Management, Business Delivery, Supply Chain, Patient Operations , ... clinical , supply chain, manufacturing, and commercialization, with knowledge of cGMP /Pharmaceutical + Implementation and rollout experience in SAP S4 HANA - +… more
- J&J Family of Companies (Spring House, PA)
- …providing quality oversight for daily activities related to commercial supply chain operations supporting production of commercial and clinical drug substance in ... and approve investigations and CAPAs, change controls, protocols, reports, area releases, project planning and site procedures. + Provide quality input on a variety… more
