- Merck & Co. (Upper Gwynedd, PA)
- …, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is responsible ... CMC - Associate Principal Scientist, CMC...pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance, n ovel modality and technologies such as… more
- Merck & Co. (Rahway, NJ)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ( CMC ) ... in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and execute… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Eisai, Inc (Exton, PA)
- …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)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and...The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- … regulatory strategy. Organizes and contributes to the timely preparation of high quality CMC sections of INDs/CTAs, NDAs, MAAs and amendments for submission ... our office three days per week on average. Position Summary The Associate Director , Regulatory CMC , is responsible for contributing to/assisting with the… more
- KOB Solutions, Inc. (Rockville, MD)
- Senior Director , CMC and Technical Operations My client...and GMP. 5. Serve as the primary interface with Quality Assurance on matters related to CMC and ... is expanding and seeks a Sr Director focused on manufacturing both API and small molecule...drug products, analytical support, formulation development, and authorship of CMC sections of regulatory documents including INDs and NDAs.… more
- ACROBiosystems Inc. (Boston, MA)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to… more
- UTMB Health (Gatesville, TX)
- …the Texas Juvenile Justice Department (TJJD). JOB SUMMARY: Serves as medical director for a number of correctional facilities within a designated region. Provides ... for all medical providers assigned within the region. Works under the director of the senior medical director . ESSENTIAL JOB FUNCTIONS: Contributes… more
- Vertex Pharmaceuticals (Boston, MA)
- Job Description General/Position Summary The Director , CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the ... inspection management related to CMC activities of the internal manufacturing site for Cell...to audit and inspection findings. Collaborates with the Global Quality Audit and Inspection Management to enable execution and… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical Lexington, MA Hybrid ... reporting (eg, key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary. Oversees & manages… more
- Mirum Pharmaceuticals (San Mateo, CA)
- …get it done, and have fun, seriously. POSITION SUMMARY The Associate Director , Global Regulatory Affairs provides management of all aspects of assigned regulatory ... related to the development and commercialization of novel liver drugs including quality , preclinical and clinical areas of drug development. This position will… more
- Legend Biotech US (Somerset, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Director , Preclinical Project Development and Strategic Lead as part of the Early-stage ... preclinical IND strategies. Accountable for preclinical IND study delivery and quality Developing and mange project plans, timelines, budgets and resources for… more
- Eli Lilly and Company (Indianapolis, IN)
- …processes for use in clinical trial manufacturing. Lead the preparation of the CMC portion of the IND/CTA/BLA/NDA. Build process capabilities for lab scale, early ... as needed in the ongoing support of marketed products manufacturing. Instill a Quality by Design mindset whereby data and learnings from smaller scales and previous… more
- Amylyx Pharmaceuticals (Cambridge, MA)
- …we encourage you to read the opportunity below and apply. THE OPPORTUNITY The Quality team is expanding and looking to hire a Manager of QC/AD, reporting to ... the Director of QC/AD. This individual will be responsible for...QC operations internally and at external CMOs/CTLs. Work with CMC Regulatory for authoring/coordinating and updating clinical and commercial… more
- Glycomine (Boston, MA)
- …opportunity to develop therapies that can provide meaningful improvements in the quality of life for patients, caregivers, and families. Job Description The Senior ... timely, on-budget trial completion that adheres to the highest quality standards. You will be a member of a...with relevant team members involved in study set up ( CMC , Reg, etc). Ensure timeline collection of all start-up… more
- Advocate Aurora Health (Charlotte, NC)
- …supporting the Radiology Service Line within one of 3 different regions: Region 1: CMC , Mercy, Cabarrus, University City, Stanly Region 2: CMC , Mercy, Pineville, ... Union, Union West, Anson Region 3: CMC , Mercy, Cleveland, Kings Mountain, Lincoln Details include: CompetitiveRates...On request, records contrast type and amount. *Evaluates technical quality of images and consults with a Radiologist if… more
