- Boehringer Ingelheim (Gainesville, GA)
- …etc. + Provides technical input and support for questions received from Regulatory Authorities in various regulatory processes, eg geographical expansion of ... and/or provides ad-hoc support to Global Supply Lead (by topic) of CMC Development sub-team. + Provides technical guidance and recommendation for user requirements,… more
- Boehringer Ingelheim (Athens, GA)
- …etc. + Provides technical input and support for questions received from Regulatory Authorities in various regulatory processes, eg geographical expansion of ... Expert or Project Contributor: + Provides support to Operations Lead of CMC Development sub-team. + Technical assessment of user requirements, product or process… more
- BeOne Medicines (Pennington, NJ)
- …regulations. The position requires strong cross-functional collaboration with Regulatory Affairs, Process Development, Manufacturing, and Quality teams, as ... written support for Investigational New Drug (IND) submissions and other regulatory documentation. + Coordinate and schedule analytical testing, ensuring thorough… more
- Merck (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... + Ensure areas of accountability are delivered in accordance with EHS regulatory and company EHS requirements. + Build robust communication channels with site… more
- J&J Family of Companies (Malvern, PA)
- …drive development strategy and execution. + Responsible for shaping external regulatory strategy through direct projects with health authorities, engagement on ... Support (10 products). Provide support in >100 countries + 20% -- Global Regulatory filings for product licensure and Shaping external Regulatory environment +… more
- Merck (West Point, PA)
- …worldwide. PCT leads process development as products enter Phase IIb through regulatory filings, process validation, and for several years beyond commercial launch. ... to commercial scale. Partners include research and development, analytical, regulatory , quality, packaging, and operations at our commercialization and commercial… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance, ... with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs, Finance, etc. of Tanabe Pharma Group, including external vendors… more
- Gilead Sciences, Inc. (Foster City, CA)
- …which spans physicochemical, compendial and plate-based assays. A strong understanding of regulatory expectations, risk assessment, and the role of rapid testing in ... & Innovation** + Demonstrate comprehensive knowledge in key analytical CMC areas: CQAs, method bridging, reference standards, comparability, and specifications.… more
- Merck (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements. + Support and/or Direct Continuous Improvement projects with automation… more
- Alloy Therapeutics (Waltham, MA)
- …from research scale to GMP production, ensuring robustness, reproducibility, and regulatory compliance. + Implement Quality by Design (QbD) principles to establish ... and finished product quality control, aligning with internal standards and regulatory expectations. Oligonucleotide Design & Chemical Innovation + Lead the design… more