- Merck & Co. (Rahway, NJ)
- Job Description Director , Combination Product Regulatory CMC - (R5)- - - This Principal Scientist position is equivalent to a Director position. Under ... direction from the Combination Product Regulatory CMC Team Leader, the Principal Scientist is responsible for...510(K)s, CE markings.- - Collaborate with Device Development, Device Quality , and other Drug stakeholders to communicate and align… 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …and accelerate process and product development and manufacturing and ensure safety and quality of our products. -The Director , Biologics Analytical Research and ... of candidates from the discovery interface, through first product registration.- -The Director will be responsible for a team of approximately 10-15 scientists and… more
- Merck & Co. (Rahway, NJ)
- …to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for ... sterile development portfolio, and delivering on organizational unit priorities.-- The Director will be responsible for new product packaging development for vaccine… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …development, and negotiate contracts.Cross functional team leadership: closely work with Quality , Legal, CMC , MSAT, Manufacturing, Supply Chain, Regulatory on ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Director , Global Sourcing (Direct Materials) as part of the Technical Operations team… more
- Merck & Co. (Rahway, NJ)
- …regulatory updates.Audit vendors/partners of SaMD/IVD/Companion DiagnosticsReports to - Director Regulatory Compliance, Device Quality and RegulatoryLocation ... Job DescriptionThis position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... & meetings with relevant domestic and international stakeholders within Novo Nordisk CMC & Product Supply. Ensure corporate level investment requirements & processes… more
- ACROBiosystems Inc. (San Diego, CA)
- …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...In a leadership role as Field Application Scientist (FAS) Manager/ Director , you will support our company goals and customer’s… 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
- Bristol Myers Squibb (Indianapolis, IN)
- …radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops and drives Quality ... the following. Other duties may be assigned. + Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. Senior Director , CMC Statistics **What you will do** Let's do this. Let's change ... and commercial products across different therapeutic areas. The Senior Director , CMC Statistics, will manage, act as...manage, act as a technical expert for, and provide quality oversight of the Global CMC Statistics… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... Communicates regulatory decisions and strategy to stakeholders in development, manufacturing, and quality + Ensures that global CMC regulatory commitments are… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …innovative CMC regulatory strategies and the preparation and submission of high‑ quality CMC sections of INDs, CTAs, and original marketing applications ... Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics...+ Directs and oversees the preparation and review of high- quality CMC related regulatory submissions and leads… more
- Lilly (Boston, MA)
- …support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide strategic and ... operational leadership for cross-functional CMC team(s) and will partner with CMC ...competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed and implement decisions. +… more
- Lilly (Indianapolis, IN)
- …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 who ... need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs -... Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC… more
- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... Teams (ASTs) and key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching asset strategy to effectively… more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… more
