- Endo International (Horsham, PA)
- …engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or ... engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or… more
- J&J Family of Companies (Malvern, PA)
- …and support processes in the cGMP facility. + Perform on the floor or desktop review of executed batch records and production documentation in support of ... Review and approve controlled documents including standard operating procedures, master batch records , test reports, COAs, work instructions, cell bank… more
- J&J Family of Companies (Malvern, PA)
- …development studies. + Perform regularly scheduled oversight of R&D GxP laboratories. + Review and approve raw material and critical reagent release for use across ... the Johnson and Johnson Innovative Medicine global network. + Review and approve controlled documents including standard operating procedures, work instructions,… more
- Actalent (Allentown, PA)
- …customer trials and sales. New projects may go through a safety review process requiring procedure development and possibly equipment modifications. The role ... includes performing instructions per test plans, maintaining batch sheets, logging data, and correcting, maintaining, participating in safety reviews, and building… more
- Merck (West Point, PA)
- …Influence CMC regulatory strategy and author DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparation for agency meetings. ... Author and review regulatory submissions. + Create the best and next...practices including working with low volume fills and small batch scale. + Experience in biologics drug product fill… more
- Merck (West Point, PA)
- …analytical execution by the contract testing lab(s) to support on time batch release. Additionally, this position will work directly with technical operations, ... regulatory, microbiology, and analytical program leaders on a regular basis to review /approve critical documents relating to analytics and participate as a site… more