- 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)
- …proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a...testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project… 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
- Repligen (Waltham, MA)
- …of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and ... OverviewWe are seeking an experienced Director of Quality candidate to lead...Auditing, Nonconforming Materials, CAPA, Validation, Change Controls, and other product life cycle management activities.Partner with cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...multiple work centers within the facility to ensure high quality and compliant product supply and oversee… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....difference? The Position Position provides field coaching, mentorship and management to the field-based Medical Liaisons, and develops and… 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 ... Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… 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
- Merck & Co. (Rahway, NJ)
- …for all product s used within the assigned program(s) ( ie Bulk Drug Product ).- - Oversees all bulk drug supply management and ensures proper allocation of ... ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical… more
- Merck & Co. (Rahway, NJ)
- …Making, Drug Product Development, Estimation and Planning, GMP Compliance, Management Process, Manufacturing Quality Control, Medical Supply Management , ... formulation and process development through process tech transfer, scale-up activities, quality investigations, change management , and authoring GMP standard… more
- Merck & Co. (Rahway, NJ)
- …process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for proactive ... talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.Current Employees… more
- Insmed Incorporated (San Diego, CA)
- …on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the ... support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage research through commercial launch. Involves hands-on… more
- Merck & Co. (Durham, NC)
- …through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- Supply ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of a HEDS Executive Director , the Senior Principal Scientist, Health Economics leads a team of health economists and outcomes ... economists and outcomes researchers.Accountable for team prioritization and development of high- quality health economic models and tools to support market access,… more
- Eisai, Inc (Exton, PA)
- …Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge ... 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
- Eisai, Inc (Nutley, NJ)
- …business decisions. Can apply financial analysis to build business cases that drive quality decision making and management processes.Travel is estimated at 30% ... If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle… more
- Merck & Co. (Rahway, NJ)
- …for upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… more
- Insmed Incorporated (Los Angeles, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director Medical Science Liaison will develop and maintain professional ... LA, Phoenix, San Diego.ResponsibilitiesResponsibilities:Engages appropriately in scientific exchanges around product information, disease education, and research ideas/activities with physicians… more
- Twist BioScience (South San Francisco, CA)
- …success.Manage the marketing budget and identify opportunities for maximizing ROI.Work with product management , digital marketing, and the regional teams to ... to lead our global marketing efforts and drive sustainable growth. The Sr Director , Marketing is responsible for leading all aspects of Twist's global marketing… 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...in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and execute… more
