- Merck (West Point, PA)
- …and influences process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC ... transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group… more
- J&J Family of Companies (Spring House, PA)
- …Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- Merck (West Point, PA)
- …leading small technical development teams + Experience in authoring and reviewing CMC regulatory documentation + Experience with process and technology transfer ... The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected… 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
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director, Physiochemical Testing Date: Nov 15, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities… 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
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Organon & Co. (Plymouth Meeting, PA)
- …+ Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other cross-functional activities, as ... be responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator Brochures, INDs,… more
- Globus Medical, Inc. (Audubon, PA)
- …studies, analytical characterization, and process validation + In-depth understanding of CMC (Chemistry, Manufacturing, and Controls) regulatory considerations + ... technical reports, and ensures strict compliance with applicable quality and regulatory standards + Possesses in-depth knowledge of CBER (Center for Biologics… more
- Lilly (Philadelphia, PA)
- …make life better for people around the world. **Organizational Overview:** CMC Project Management is responsible for leading the creation, development, communication ... and implementation of integrated CMC plans for assets from portfolio entry to global...goals (working closely with asset leadership, PPM, clinical/medical, and regulatory partners). + Lead the creation, development, communication and… more