- Legend Biotech USA, Inc. (Raritan, NJ)
- …administrative support activities.Supports scheduling for metrology and facility and project initiatives as needed which includes engineering, maintenance and ... local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …designated programs.Ensure proactive representation of Quality professionals at strategic non- project team and at MA strategic discussions.Lead the Quality Reviews ... MA activities for internal QA team (global/ local), but also to:Global Project TeamsGOMA and Specialty MA Management teamsData Management/ Biostats Clinical Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategiesExecutive Advisory Communications: provide strategic insights and deliver concise updates on project statuses and next steps to prepare the Head of Late ... input and facilitate efficient decision makingIn conjunction with finance and Project Management support the Head of Oncology Late-Stage Development in management… more
- Merck & Co. (Rahway, NJ)
- …a motivated scientist with technical expertise in Biologics Potency assays in drug Development. More specifically, the ideal candidate will be a recognized expert ... assays for the development of therapeutic proteins, monoclonal antibodies, antibody- drug conjugates, and/or new modality-based products.-- The successful candidate… more
- Genmab (NJ)
- …and data consistency across programs as well as provide project -specific work as needed.ResponsibilitiesStrategic and Operational LeadershipDefine and implement ... and industry data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and inspection readiness… more
- Merck & Co. (Rahway, NJ)
- …screening, design, and development of formulations defined by robust drug product compositions and processes.-Other responsibilities include statistical experimental ... development teams while interfacing with other functional areas (eg project management, manufacturing, quality, regulatory affairs) and external partners to… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... hands-on experience with a range of analytical instrumentation, with each project offering new scientific challenges and learning opportunities.Participate in sample… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are conducted.Oversee and guide quality assurance processes related to project specifications, ensuring standard procedures are followed.Deploy a risk-based approach ... of ICH- GCP including FDA/EU / PMDA regulations, pharmacovigilance, new drug regulations, other key HA guidance's, and current industry practice.Demonstrated… more
- Merck & Co. (Rahway, NJ)
- …and geographies. Demonstrated capacity to solve complex technical challenges, lead project teams, and influence stakeholders effectively. A solid understanding of ... Material(s):n/aRequired Skills:Adaptability, Adaptability, Applied Engineering, Automation Systems, Business, Capital Project Management, Change Management, Chemical Manufacturing, Clinical Manufacturing, Compliance… more
- Merck & Co. (Rahway, NJ)
- …specific role will be responsible for advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible ... risks worthy of escalation versus typical uncertainty associated with drug development, commercialization, and/or supply. Productive Communication :--Plans and… more
