- Legend Biotech USA, Inc. (Raritan, NJ)
- …and peers.Harmonize with Environmental, Health, and Safety personnel, Product Development , and Quality/Manufacturing personnel.Independently makes appropriate ... improvement ideas and independently implement associated solutions.Support QPIP team development .Must be able to be Aseptic Gown QualifiedPossess the ability… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project management office to enable robust production, testing and release of product to patients.Key Responsibilities Helps to develop and support implementation of ... Finance team member, and functional line representatives on the teamResponsible for development and management of the communication plan for the project, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a strong, compliant program to enable robust production, testing and release of product to patients in a cGXP environment.Key Responsibilities Acts as a subject ... controls (Deskman, Windows, etc).Executes, owns, assesses and participates in the development , revision and review of change controls, SOPs, and other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …critical process parameters (CPP) data, in-process testing data, and drug product release data to identify out-of-trend performance.Assist investigation and root ... for BS/MS, 3 years for PhD of industrial biologics CMC development or manufacturing experience, Cell therapy manufacture experience is highly desirable.Proficient… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Demonstrates professional execution of the planning, ... development , and implementation of construction and/or repair programs for engineering driven initiatives. Serves as SME on engineering design projects; sets project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …relevant cross functional groups to enable robust production, testing and release of product to patients. This individual will be an integral part of the CAR-T ... -preferredExperience with managing utility and/or process equipment from specification development through full implementation in a GMP Commercial FacilityExperience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …according to cGMP requirements. This individual will also oversee the hiring, development , and performance management of staff, and assign personnel to execute daily ... work centers within the facility to ensure high quality and compliant product supply and oversee production metrics. This individual will support manufacturing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Mixed Modalities team within the Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, ... Chemistry, Biochemistry or related discipline Required Experience and Skills :Deep drug product development expertise with exposure to all stages and aspects of … more
- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead, Oncology Global Clinical ... Job DescriptionOur Clinical Development teams manage studies to provide the safety...PDT lead will manage the entire cycle of clinical development , including development strategy, study design, initiation,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company's Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused scientist.This ... terms to facilitate cross-functional understanding and to support project timelines. Development experience in risk-oriented, regulated environmentsDevelopment project leadership with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP) Development of clinical sections of trial-level regulatory documents ... (eg, DMC, Endpoint Committee, SC, Ad boards).TPP and EPP (Expected Product Profile) development in collaboration with peer functions and CSOversight of Academic… more
- Merck & Co. (Rahway, NJ)
- …or PhD) preferred.15+ years of experience in medical device engineering, combination product development , or related technical fields, with a minimum of ... stewardship, supply, or related functions.-Strong understanding of medical device and combination product development and support from early stage through launch… more
- Merck & Co. (Rahway, NJ)
- …years of experience in project management or a related role required - Product development experience required ; in a pharmaceutical/biotech industry preferred - ... Job Description Job Description: - The drug development Project Manager is part of Global Project...Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering… more
- Merck & Co. (Rahway, NJ)
- … plans from the ground up. They will also be responsible for guiding Product Development Team Leaders and Clinical Directors within their group to ensure ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development , Respiratory will focus on driving strategy, development , and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project ... defined based on the project needs and the respective development stage of the project. The CMC Lead will...transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and… more
- Merck & Co. (Rahway, NJ)
- …Dysfunction-Associated Steatohepatitis (MASH).The individual will be responsible for overseeing Product Development Team Leaders and-Clinical Directors within ... Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy, development , and life-cycle… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the 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 ... to PPG and Brands EBT. Essential Functions Evidence Generation Provide input to Product Development Plan (PDP) and Evidence Generation Plan (EGP), in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …direction and initiatives within the TA. This role is responsible for guiding product development and commercialization strategies for late stage and in-line ... Nordisk's Rare Disease portfolio. The mandate of STARS is to facilitate the development and to coordinate the execution of the long-term strategy, defining a… more
- Merck & Co. (Rahway, NJ)
- …with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch.- ... to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead and set direction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …group for dose escalation decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, ... About the Department Our East Coast Global Development Hub brings together the best minds in...with no direct reports. Essential Functions Establishment of the product safety profile Develop and update the minimum mandatory… more
