- Teva Pharmaceuticals (West Chester, PA)
- …teams, with ability to build cross-departmental relationships * Knowledge of CMC requirements for regulatory submissions (INDs, BLAs) and experience ... Our multidisciplinary team advances biologics and biosimilars. Within Teva, Biologics CMC oversees biologic product development from IND submission through BLA… more
- Merck (West Point, PA)
- …(DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more
- Merck (West Point, PA)
- …scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls ( CMC ) documents for global regulatory submissions, and responses to ... Experience with method development and validation + Familiarity with authoring relevant CMC sections of regulatory submissions Current Employees apply HERE… more
- Merck (West Point, PA)
- …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- System One (Exton, PA)
- …Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions. + Author investigations, ... deviations, change controls, and other non-conformance records. + Work with vendors to coordinate testing and arrange shipments as needed. + Compile and review scientific data for completeness as needed. + Perform trending and evaluation for continuous… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ). **BENEFITS** + Medical, ... Dental Vision + 401K + Paid time Off \#LI-Hybrid **Our Benefits** CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and… more
- Deloitte (Pittsburgh, PA)
- …experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and ... automation for pharmaceutical regulatory content or regulatory intelligence; Veeva RIM...generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Understanding of… more
- Cytel (Harrisburg, PA)
- …Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls ( CMC ) data analysis. You are excited and enthusiastic, motivate your teams to ... **Position Overview:** We are seeking a highly motivated Biostatistician to support CMC projects across the drug development lifecycle. The ideal candidate will have… more
- J&J Family of Companies (Malvern, PA)
- …to a matrixed team, in addition to representing Advanced Therapy (BioTD-AD) on the CMC team(s). This role is also responsible for working with teams in the ... preparation of technical documents and regulatory submissions, participating in review, and contributing to development of strategies to follow global requirements.… more