- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products ... - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in...regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC , Statistical Design of Experiments (DOE),… more
- Organon (Plymouth Meeting, PA)
- Job Description The Position The Principal Scientist ( Director ) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… more
- Formation Bio (New York, NY)
- … leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products, ... & External Partnerships Partner closely with analytical development, manufacturing, quality, and regulatory teams to ensure seamless execution of CMC plans.… more
- Eli Lilly and Company (Indianapolis, IN)
- …all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical… more
- Merck & Co. (Rahway, NJ)
- …areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting,… more
- Eisai, Inc (Exton, PA)
- …as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... Director in Biologics Cell Culture Sciences group and working...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
- Bristol-Myers Squibb Company (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance ... develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in… more
- nChroma Bio (Boston, MA)
- …regulations related to QC. The candidate's ability to represent the AD/QC function in Regulatory CMC meetings and drafting the Module 3/IB documents is a must. ... troubleshooting. *Author QC related SOPs, CAPAs and Change Controls. *Work with CMC Regulatory for authoring/coordinating and updating clinical and commercial… more
- Cedent (Cambridge, MA)
- Summary: Reporting to the Chief Medical Officer and collaborating with external regulatory advisors, this role is responsible for developing and executing ... regulatory strategies from early development through late-stage clinical programs....strategy development, global submissions, agency meetings, and expedited designations; CMC experience is a plus. Experience in ophthalmology is… more
- Vaxcyte (San Carlos, CA)
- …and ensure safety and compliance of validation activities including support for regulatory filing, inspection, and other CMC and technology team activities. ... Interface - Collaboration with cross-functional teams across the network, including Regulatory , CMC , Quality, Supply Chain, Procurement, and Process Engineering,… more
- EPM Scientific (Rockville, MD)
- …site-wide cleaning validation and contamination control strategies aligned with regulatory expectations and industry best practices. Provide deep technical expertise ... years of experience in biopharmaceutical process development, MSAT, or CMC roles. Extensive experience with commercial-scale cleaning validation and contamination… more
- General Proximity (San Francisco, CA)
- …CMC Preclinical PK/PD/efficacy relationships and their clinical translation Collaborating with regulatory , CMC , and clinical groups to develop strategic ... that enable compliant IND submissions and establish clear development paths Regulatory processes relevant to IND submissions Recruiting, mentoring, and developing a… more
- Neurocrine Biosciences, Inc. (San Diego, CA)
- …project teams (including clinical operations, preclinical/clinical pharmacology, biometrics, regulatory , drug safety, CMC ). Responsible for medical ... Facebook. (*in collaboration with AbbVie) About the Role: The Executive Medical Director will be primarily responsible for developing and executing the Neurology… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. Represents CMC on cross-divisional governance and development teams while providing strategy… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). Minimum of 5 years' experience as a… more
