- Merck & Co. (Rahway, NJ)
- …antibodies, and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative… more
- Merck & Co. (Rahway, NJ)
- …, Chemistry, Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance, Management ... Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing… more
- Merck & Co. (Rahway, NJ)
- …(Master's or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering , with at least 5 years in a leadership or ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a...in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering , Biomedical… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early… more
- Merck & Co. (Rahway, NJ)
- …Knowledge of Regulations/Industry Guidance (NFPA, ATEX, CE, And OSHA)Process And Product Safety TestingReviewing And Developing Safety and Engineering Standards ... during project implementation, including Commissioning & Qualification. Direct work of Engineering Firms and supplier/vendors (no direct reports) to progress project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms… more
- Merck & Co. (San Francisco, CA)
- …Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for ... , Compliance Frameworks, Cross-Cultural Awareness, Decision Making, Feasibility Studies, Management Process, Managing Engineering Teams, Operational Metrics,… more
- Formation Bio (New York, NY)
- …transitioning proof-of-concept efforts into scalable products through close collaboration with engineering and product teams. These predictive models will ... models that drive drug acquisition and portfolio optimization decisions Partner with engineering and product teams to transition proof-of-concept models into… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of… more
- Repligen (Waltham, MA)
- …Auditing, Nonconforming Materials, CAPA, Validation, Change Controls, and other product life cycle management activities.Partner with cross-functional ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...quality assurance team which includes all day-to-day activities for product manufacture, test and release including deviation support, root… more
- Eisai, Inc (Exton, PA)
- …with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains ... 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. (Durham, NC)
- …and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also ... goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).-… 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 ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities ... related to biologic product development at Formation Bio. This is a strategic...and support decision-making in biologics development and manufacturing. Project Management Own CMC timelines, budgets, and resources across biologics… more
- Repligen (Clifton Park, NY)
- …a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will play a ... operations at the site, including Planning, Procurement, Manufacturing, Distribution, Engineering , Quality and Customer Service Order Processing.Hire Operations leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …AI CoE and provide input for the vision and direction of AI product deployment and governance to ensure responsible and efficient application of AI technologies.To ... senior leaders to drive strategic analytics transformations.Partner with Data Strategy, AI Engineering , and IT teams to ensure a strong data and technology… more
- Merck & Co. (Durham, NC)
- …blood test, chest x-ray Position Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a new facility in ... facility will include end-to-end processing of both drug substance and drug product , including product inspection, warehouse, utilities, and quality control… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to...The Position The Manager - Market Access Insights assesses product and customer performance for all customer segments and… more
- New York State Civil Service (Albany, NY)
- …Information Technology Services, Office of Title Center of Excellence Director - Product Management Occupational Category IT Engineering , Sciences Salary ... in customer-facing cloud operations, 5 years of experience in management consulting and product management ...that you are applying for the Center of Excellence Director Project Management position and include the… more
