- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to proactively perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and ... perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director, Clinical Safety , will be a product safety lead or part of a product safety team, ... and be responsible for overall product safety strategy or specific areas of safety ...Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact ... and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D...the person filling this role will pioneer and eventually lead a new group within CSPV. He/she will spearhead… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... hands-on work in applying regulatory guidance and quality standards related to product release and safety . #EligibleforERP #AR&DNOTICE FOR INTERNAL APPLICANTSIn… more
- Catalent (PA)
- Proposal Lead I Summary Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to ... Biologics is positioned to drive significant growth for Catalent.The Proposal Lead I works closely with Business Development (Sales), Program Management, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GPT Leader , directly accountable for conceiving, designing and implementing product development strategy and delivery for their asset(s). The GTL has end-to-end ... rare diseases and immune disorders. Summary The Global Team Leader , is a senior, cross-functional leader in...In this key role, the candidate will have to lead a complex, global team in charge of a… more
- Merck & Co. (Durham, NC)
- …therapies for our patients. We work in the manufacturing plants with a " Safety First, Quality Always" mindset, striving for continuous improvement, and earn our ... new facility will include end-to-end processing of drug substance, drug product , including biotech culture growth, harvest, lyophilization, product inspection,… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … more
- Merck & Co. (North Wales, PA)
- …with squad members including but not limited to scrum masters, technical lead (s) and development team to manage high-quality product delivery leveraging ... the Clinical Research to analyze data for efficacy, dosing, safety profiling and adverse events. The data collected from...the transition from project / portfolio-based execution to the product model, it is important to have an experienced… more
- Catalent (St. Petersburg, FL)
- Associate Scientist I II , Product Development Position Summary Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... development and manufacturing challenges . The Associate Scientist III, Product Development contributes significantly to the successful timely development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For ... EOP2 meeting and represents clinical/TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational study(ies); Develop prospective… more
- Merck & Co. (Rahway, NJ)
- …degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth ... of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations/change… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... development. Are you ready to maximize your potential with us? The Position The Product Manager is driven by a customer-centric mindset to meet business goals by… more
- Catalent (St. Petersburg, FL)
- Manager, QA ( Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations, Deviations,… more
- Catalent (CA)
- Account Executive, Pharma Product DeliveryCatalent Pharma Solutions is recruiting for an Account Director, Pharmaceutical Softgel and Late-Stage Oral Solids. This ... your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product...your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring ... initiatives to enhance investigation quality, timeliness, and productivity.Key Responsibilities Co- Lead Deviation Investigations: Collaborate closely with the Quality Associate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, ... New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …risk management tools and resources.Responsibilities- Strategic Advice and Support to Global Product Teams: 1) Provides expert, strategic advice on the creation and ... aware of any gaps in risk management planning, creation, and execution- Lead /Manage RMP initiatives. Lead and/manage RMP initiatives and activities related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Team members, and peers. Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel. Independently ... Experience directly supervising employees is preferred. Ability to work with and lead others in a team environment. Demonstrated ability to develop and set… more
