- 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) activities related to biologic product development at Formation Bio. This is a strategic...goals and global regulatory standards. Team Development Build and lead a high-performing CMC team; foster a culture of… more
- Formation Bio (New York, NY)
- …the PositionAs AD/Director of Data Science - Platform at Formation Bio, you will lead one of two critical arms of our Data Science function, focusing on building ... efforts into scalable products through close collaboration with engineering and product teams. These predictive models will seamlessly integrate with our Clinical… more
- Merck & Co. (Rahway, NJ)
- …be highly adept at presenting and reviewing device and combination product strategies and development efforts in senior -level governance reviews.-Furthermore, ... from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Combination Product Working Groups to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The… more
- Merck & Co. (Rahway, NJ)
- …Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing ... in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication… more
- Merck & Co. (Rahway, NJ)
- …antibodies, and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, ... collaboration skills.-A strong track record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials for program presentations ... without formal authority; ability to influence and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...used within the assigned program(s) ( ie Bulk Drug Product ).- - Oversees all bulk drug supply management… more
- Merck & Co. (Rahway, NJ)
- …Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management ). Lead Periodic Business and Operations Review Meetings ... goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).-… more
- Tris Pharma (Monmouth Junction, NJ)
- …lead for assigned projects regularly reporting status/issues to management , conducts laboratory investigations and recommends appropriate Corrective Action ... New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior … more
- Merck & Co. (Rahway, NJ)
- …interact and increase effectiveness by enabling clear, concise communication directly to senior management at our Company.Partners with members of GRACS ... regulatory operationsProviding strategic and tactical direction and execution of cross product and GRACS cross functional projects and teams as assigned.Key… more
- Merck & Co. (Rahway, NJ)
- …development.Experience with planning and execution of strategies for product registration and commercialization/ life-cycle management .Strong leadership ... Innovation, New Technology Integration, Operational Excellence, Oral Communications, Pharmaceutical Management , Product Registrations, Professional Networking, Project … 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 ... Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management . This role fulfills the PV Oversight function in PV deviation … 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 ... function within the role of Quality Business Partner where requested by management Develops comprehensive, relevant resources (eg training program, FAQs) to enable… more
- Merck & Co. (Rahway, NJ)
- …to communicate program progress, issues, and mitigation plans to the senior management .Innovative mind-set demonstrated by technical accomplishments, external ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… 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 ... and payers in order to optimize market access and patient outcomes.Main Responsibilities: Lead a team in HEDS to develop and implement health economic models and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, ... 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… more
- Eisai, Inc (Nutley, NJ)
- …and comfortable presenting to all levels of an organization including its Senior Management . Strong personal and interpersonal skills, including the ability ... for development of global regulatory strategic plans for new product development, as well as life cycle management...management of existing products. May serve as the lead regulatory representative on the project team throughout the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to issues, and demonstrated passion for creating new medicines.Leadership & People Management : Proven ability to lead cross-functional teams, manage performance, ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights to inform portfolio strategy decisions Excellent communication and stakeholder management skills, with ability to influence senior leaders and ... in alignment with organizational goals especially as it relates to early-stage product , portfolio prioritization, lifecycle management , etc. Ability to manage… more
