- Merck & Co. (Millsboro, DE)
- Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... and Business support at the Millsboro site. The Site Digital Technology Lead ensures all project and commercial manufacturing activities are supported and delivered… more
- Catalent (Manassas, VA)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. As...Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading the… more
- Merck & Co. (Boston, MA)
- …notebook entries.Participate in partner site visits to evaluate processes, capabilities, safety procedures and compliance standards as well as build workflows to ... data QC, protocol design, laboratory processes and best-practices, as well as safety standards.A minimum of 3 years in managing CRO relationships or equivalent… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Principal Scientist, Upstream Bio Process Development BPR&D within our Company's Research Laboratories is on a mission to ... Manufacturing while providing a diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the creation and submission of RMPs and REMS. 2) Own and maintain the process for creating RMPs. 3) Provides expert, strategic advice on executing the requirements ... aware of any gaps in risk management planning, creation, and execution- Lead /Manage RMP initiatives. Lead and/manage RMP initiatives and activities related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process in collaboration with the study ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead innovation, coordination, and strategic planning efforts and will be responsible to ... management and operational excellence and the ability to drive innovation and process improvement within a global matrix organization, driving the implementation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process in collaboration with the study ... primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical… more
- Merck & Co. (Durham, NC)
- …strong interpersonal, communication, and collaboration skills responsible for supporting the manufacturing process . Individual will possess the ability to lead a ... prepares equipment used in production. Identifies and addresses compliance, environmental, safety , and process deviations as appropriate while notifying… more
- Merck & Co. (Durham, NC)
- …Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment operations. Takes appropriate action to correct Plant Engineering ... tasks, as needed: Ability to work with and troubleshoot complex process systems.Routine maintenance tasks including but not limited to diaphragm/gasket replacement,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …education, and process development projects, as requiredMay serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical...clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA… more
- Merck & Co. (Rahway, NJ)
- …in support of various research programs.The Associate Specialist will also be expected to lead process improvement initiatives (such as a project to collate raw ... Support role involves working directly with the Prep Lab lead supporting scientific teams who are preparing for manufacturing...is compliant with various site requirements (eg, environment and safety ) and other regulations as needed, and that the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of the Investigator's ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Merck & Co. (Durham, NC)
- …HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team and be accountable for all human ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Merck & Co. (Rahway, NJ)
- …They will work closely with the development engineers & chemists, compliance representatives, safety partners and other team members to ensure the quality and safe ... operations, support compliance investigations/change management, author GMP documentation and manage/ lead engineers in any of our enabling facilities. Additional… more
- Merck & Co. (Rahway, NJ)
- …all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for ... products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but are not limited to:Reports to Executive… more
- Merck & Co. (Durham, NC)
- …teams to advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with equipment, ... candidate should be able to examine an issue from diverse perspectives ( safety , compliance, automation, equipment, process , and people) to best understand… more
- Novo Nordisk Inc. (Durham, NC)
- …Management (Mdev LCM) in Emerging Technologies (ET) for the production site. Lead strategic activities ensuring new products can thrive without disrupting the ... and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead , drive & coach teams to ensure a high performing collaborative… more
- Catalent (St. Petersburg, FL)
- …a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Quality Auditor will be ... teams globally during the management of supplier quality issues Lead and support Supplier issues / investigations affecting Catalent...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Catalent (Philadelphia, PA)
- …Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Responsible for ... all QA activities related to incoming, distribution and destruction and process auditingAssist in ensuring the quality and identity of pharmaceutical products during… more
