- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and ... platforms, novel dosage forms, novel unit operations, etc. The Director , AMT Biologics Programs is responsible for...-related initiatives.o Identify opportunities to develop written and physical standards to support AMT for biologics in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **TITLE:** **Senior Director , Analytical Lifecycle Management - Biologics Quality Control ... biologics drug substances and drug products. The Senior Director collaborates with cross-functional teams, fosters a culture of continuous improvement,… more
- Astellas Pharma (Northbrook, IL)
- …more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their ... in remote work are encouraged to apply. **Purpose and Scope:** The Director , Global Clinical Pharmacology will have ultimate responsibility and accountability for… more
- Catalent Pharma Solutions (Bloomington, IN)
- **Job Title: Sr. Director , Technical Services** **Location: Bloomington, IN** **Position Summary:** Catalent Biologics is a fast-growing business within Catalent ... new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Squibb External Manufacturing is looking to recruit a permanent **Associate Director , Strategic Sourcing and Procurement, API, Global Product Development and ... role will also have significant linkage into Oral Solid Dose Drug and Biologics categories. This role focuses on the development of category strategies that define… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... by leveraging our world-class science and technology. With more than 100 years of...around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory… more
- Merck (Columbus, OH)
- …tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our ... every time, across the globe. **Position Responsibilities:** + The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits… more
- Boehringer Ingelheim (Ridgefield, CT)
- …regulatory science and global regulatory requirements, guidelines, developments, and standards , allowing for informed comments and input to a broad spectrum of ... programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Global Regulatory Strategy Lead will provide strategic regulatory guidance and… more
- Merck (West Point, PA)
- …Our Company's R&D IT brings together product management, engineering, and data science expertise to enable data and technology products and services that accelerate ... research to support our organization's target and biomarker discovery, chemistry, Biologics , Vaccines, safety, and process and analytical R&D efforts. The ideal… more
- Bristol Myers Squibb (Summit, NJ)
- …external and internal manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy ... manufacturing network. We are looking for a director to join our Process Robustness team within the...Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing: Master's degree with 12+ years or… more
- Actalent (Paramus, NJ)
- MUST BE ON-SITE IN PARAMUS, NJ 5 DAYS/WEEK The Associate Director , Clinical Operations is responsible for oversight of US clinical development providing vision, ... leadership, and mentoring of staff. The Associate Director is also a valuable team member providing input into clinical trial implementation, execution, and outcome,… more
- Astellas Pharma (Westborough, MA)
- …the site to manufacture clinical and commercial products to the highest standards of cGMP manufacturing. **Organizational Context:** The Director , Manufacturing ... ** Director , Manufacturing Operations** Do you want to be...around the world. We are committed to turning innovative science into medical solutions that bring value and hope… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Quality System Compliance Date: Apr 10, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 55102 **Who we ... a difference, and new people to make a difference with. **The opportunity** The Director of Global Quality Systems Compliance plays a critical role in overseeing and… more
- Sanofi Group (Bridgewater, NJ)
- …in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations + Ensure ... degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science , or related field) preferred **Experience/Professional requirements:** + US regulatory expertise in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... by leveraging our world-class science and technology. With more than 100 years of...across functions on key regulatory topics, particularly relating to biologics and Oncology, incl. coordinating Reg Intelligence & Policy… more
- AbbVie (Worcester, MA)
- …Job Description AbbVie Bioresearch Center (ABC) is hiring an Associate Director Automation & Manufacturing Systems position to lead the Operational Technology ... in a proactive and motivating team environment. The Associate Director Automation & Manufacturing position will afford you the...opportunity to lead a technical team within a multi-product biologics manufacturing facility. In this role, as head of… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …maintaining GxP computerized systems are doing so in accordance with Teva policy, standards and procedures. The Senior Director IT Quality Compliance leads the ... Sr Director , Global IT Quality Compliance Date: Apr 26,...IT and business stakeholders + Continuously improve the policy, standards , procedures, tools and training related to cGxP CSV… more
- Sanofi Group (Bridgewater, NJ)
- …in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations + Ensure ... degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science , or related field) preferred **Experience/Professional** **requirements:** + US regulatory expertise… more
- Lilly (Cambridge, MA)
- …fulfilling this mission. The Innovation team will consist of core technology-focused science and engineering fields along with key external innovation subject matter ... improvements in healthy outcomes for our customers. We are seeking an Executive/Senior Director - DDCS Drug Delivery and New Product Innovation to partner with R&D… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... by leveraging our world-class science and technology. With more than 100 years of...around rare diseases and immune disorders. **Summary** The Senior Director , Global Oncology Medical Affairs is responsible for developing… more