- Merck & Co. (Rahway, NJ)
- …IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production with respect to device ... device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position… more
- Formation Bio (New York, NY)
- …additional internal and external researchers/writers to contribute sophisticated content, and lead editorial and production for that content. Event Curation ... external branded content, from ideation and drafting through editing and production . Develop strategic, high-quality content across multiple formats (written, audio,… more
- Merck & Co. (Rahway, NJ)
- …(INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead / Support clinical supplies production with respect to device ... DescriptionJob Description Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination… more
- Merck & Co. (Rahway, NJ)
- …with high throughput bioreactor systems, benchtop scale bioreactors, and/or production scale bioreactors.Experience with the design, optimization, and scale-up of ... and collaboration skills.Good organizational, interpersonal, writing, and time management skills. Lead and operate within a cross-functional process development team.Preferred… more
- Merck & Co. (Rahway, NJ)
- …sites.The SSO Operations Specialist will provide hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Merck & Co. (Rahway, NJ)
- …collaborate in a fast-paced multidisciplinary team environment. Primary Duties: Lead /contribute towards the new, innovative approaches for small molecule, ... multi-task, mentor scientists, and a strong desire to learn and contribute. Lead project activities at external manufacturing sites including tech transfers; manage… more
- Merck & Co. (Rahway, NJ)
- …Experience with high-throughput experimental techniques Demonstrated ability to lead collaborative multi-disciplinary teams to successful outcomes Demonstrated ... development Experience with fermentation process development for enzyme or protein production Experience with a range of recombinant host organisms Experience with… more
- Merck & Co. (Rahway, NJ)
- …as well as developing and enhancing solutions over time.Perform as a Team Lead who is hands-on and utilize demonstrated experience in developing and maintaining the ... entails: Support dashboards in self-service mode - Planning / Development & Production Enhancement Requirements / User training / Co-ordination to align with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …duties will be performed within a team-based environment, on an assigned production shift schedule.Key Responsibilities Lead and supervise multiple units within ... position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting ... assurance procedures processes, and documentation to ensure the consistent production of safe, effective, and high-quality pharmaceutical products. Cultivate support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will ... are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the establishment and management of… more
- Formation Bio (New York, NY)
- … production of safe, effective, and high-quality pharmaceutical products. Lead internal and external audits to assess compliance with regulatory requirements, ... improve quality performance. Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Cleaning Validation Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Cleaning Validation Lead ... following necessary FDA / Annex 1 requirements. This person will be the lead for cleaning validation program, working cross functionally with various departments to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a ... including conduct of impact assessments and implementation of changes as required. Lead development and maintenance of RBQM standards such as guiding principles,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaboration with management in Operations to support personalized cell therapy production through safe and compliant operations according 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 facility for commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Content Program Manager will report into the Content Management Lead , within the broader Experience Operations vertical. They provide direct support ... between cross-functional teams. By leveraging a deep understanding of content production workflows and best practices, drive efficiency, quality, and innovation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operation and Quality functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP ... groups to establish a strong project management office to enable robust production , testing and release of product to patients.Key Responsibilities Helps to develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... Raritan site to support production processing while liaising with other functions including but...solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity,… more
- Genmab (Plainsboro, NJ)
- …commercial displays, exhibits & sponsorships; Promotional materials reviews; Print production ; Management of external vendors; and interaction with alliance ... manage flawless program execution & compliant reconciliations & reporting. Lead cross-functional colleagues including field representation, sales operations, BIS,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Senior Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and ... knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective investigations Proficiency with Microsoft Office Excellent… more
