- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages with leadership… more
- Merck & Co. (Rahway, NJ)
- …and academic or industrial partnerships.- In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead also plays a key role ... Job DescriptionThe Chemical Engineering Research & Development department (CERD), part of...seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and… more
- Genmab (Plainsboro, NJ)
- …handling, and cold chain management.Proven experience working with CMOs for clinical trial supplies, including vendor management.Ability to lead cross-functional ... purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global ...to ensure scalability.It is expected that you will take lead of strategic initiatives, mentor colleagues, and resolve complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Rahway, NJ)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a… more
- Merck & Co. (Rahway, NJ)
- …Engineer Job Description: The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated ... high degree of technical and project management responsibility. The Specialist -Prep Lab Engineering position will report to the Director, Engineering and will… more
- Merck & Co. (Rahway, NJ)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Pharmaceutical Sciences and Clinical Supplies (PSCS) organization translates molecules to medicines, working from the discovery ... strategy, scientific understanding and capability builds within the organization.Primary Responsibilities:Responsibilities: Lead development of new, innovative approaches for product development,… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of ... models, quantitative system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to improve cycle… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This ... and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that… more
- Merck & Co. (Rahway, NJ)
- …programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into ... and colleagues in other related function areas. Primary Activities : Lead programming deliverables for multiple studiesProvide technical consultation and analytical… more
- Merck & Co. (Rahway, NJ)
- …PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs ... Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author… more
- Merck & Co. (Lower Gwynedd, PA)
- …in Lower Gwynedd Township, PA.We are seeking a talented, organized, and innovative leader to lead our Laboratory Operations and System Validation team. The ... and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) Vaccines bioanalytical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Regulatory Affairsis a strategic leader responsible for directing and managing regulatory strategies for multiple pipeline and ... clients and internally with several departments including R&D, Quality, Facilities, Engineering to support their initiatives. The Director of Regulatory Affairswill… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... a difference? The Position This role sits in the Clinical Data Sciences and Evidence (CDSE) Division. It plays...colleagues in the Modeling team and HEOR teams to lead and execute HEOR modeling projects. Essential Functions Develop… more
- Aequor (Seattle, WA)
- …experience would be considered overqualified for this role.Cell Culture Experience.Cell Engineering Experience Preferred. Position SummaryCell Therapy is one of the ... a Scientist within the Cell Therapy Analytical Development Organization to lead potency assay development and functional characterization for cell therapy products.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems ... engineering team. This role will require technical expertise and...of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions… more
