- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …downstream process technology transfers to CDMOs, including documentation review, gap analysis , and risk assessment. + Provide expert technical oversight of ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- J&J Family of Companies (Spring House, PA)
- …CPP deliverables including but not limited to shell drafts of pharmacometric analysis and data transfer plans, pharmacometric memos and reports, and other types ... the coordination of consistent document uploads within the required regulatory document management system. Driving effective contributions to process enhancements… more
- PNC (Pittsburgh, PA)
- …* Experience dealing with clients in a comprehensive and complex regulatory environment * Sound independent judgment, finely-tuned problem-solving skills, and ... legal work while regularly interacting with management. Oversees legal research, analysis , consultation, and documentation within a framework of legal compliance and… more
- PNC (Philadelphia, PA)
- …short and long term basis * Complete complex fiduciary investment risk quantitative analysis ; and develop tools to help manage, measure, and monitor portfolio risks. ... * Develop performance analytics and conduct portfolio performance attribution and analysis * Communicate results and analysis of fiduciary investment risks to… more
- University of Pennsylvania (Philadelphia, PA)
- …researcher will need experience in molecular virology, including PCR, sequence analysis , cloning, infectivity and entry assays, and other cell culture-based ... Prior experience working with viruses and BSL II agents is preferred. PhD with several years of experience post-graduation is preferred. The individual will… more
- Northrop Grumman (PA)
- …systems. + Assures supplier process and product quality, including contractual, regulatory , and technical compliance. + Interfaces directly with supplier personnel ... supplier quality performance, and drives root cause corrective action analysis for supplier quality issues. + Manages supplier requests...3 or more years of relevant experience, or a PhD with 1 year experience. + Sr. Principal Engineer… more
- Merck (West Point, PA)
- …and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, activities include site-to-site process ... next generation process development and characterization, process validation, and regulatory submission authoring. This role may require working outside of… more
- Merck (West Point, PA)
- …global auditing team + Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into the ... to these requirements. + Provide updates to company stakeholders on GxP and regulatory trends as well as the auditing program's ability to detect compliance to… more
- Pfizer (Collegeville, PA)
- …clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents. + Provide leadership to ... with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with the Pfizer Oncology group… more
- Merck (West Point, PA)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... field. Expertise in independently conducting and directing the planning, execution, analysis , and documentation of all stages of cell culture process… more