- Kelly Services (Malvern, PA)
- …phase changes of API clinical materials per Chemistry, Manufacturing, & Controls ( CMC ) timelines. **New Product Introduction (NPI) Tech Transfers** + Accountable for ... departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead Process-Fit-to-Plant… more
- J&J Family of Companies (Spring House, PA)
- …discovery and clinical application, encompassing Chemistry, Manufacturing & Controls ( CMC ), Device Development, and Clinical Supply Chain. This organization ensures ... delivery system is robustly developed, scaled, and supplied under rigorous quality and regulatory standards. We are seeking a Global Head of Data Science & Digital… more
- Organon & Co. (Plymouth Meeting, PA)
- …Safety Assessment Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of strategy across the ... Additionally, cross-functional interactions with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project ... study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical… more
- Merck (West Point, PA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams. + **Reporting & ... on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- …and lead strategic initiatives. Demonstrated ability to successfully interact with regulatory agencies and direct experience with site regulatory ... regulations.Quality systems, batch documentation, and inspection readinessTechnology transfer, including CMC documentation and scale-up proceduresSupply chain operations, vendor qualification,… more
- J&J Family of Companies (Spring House, PA)
- …by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical ... as needed. + Collaborate proactively with Chemistry, Manufacturing and Controls ( CMC ) functions to assure drug substance quality. + Participate in external… more
- J&J Family of Companies (Spring House, PA)
- …by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical ... (L&A) opportunities. + Collaborate proactively with Chemistry, Manufacturing and Controls ( CMC ) functions to assure drug substance quality. + Actively participate in… more
- J&J Family of Companies (Malvern, PA)
- …protein biotherapeutic drug products and delivery strategies as part of the broader CMC function. **You will be responsible for:** + Devise and implement formulation ... with a high degree of independence **Preferred:** + Understanding of regulatory pathways for biotherapeutics; experience with authoring and reviewing regulatory… more
- J&J Family of Companies (Malvern, PA)
- …systems in GxP environments, including background with systems validation and regulatory compliance requirements is preferred + Experience with various programming ... Skills:** Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control ( CMC ), Clinical Research and Regulations, Clinical Trial Designs, Coaching,… more