- Legend Biotech USA, Inc. (Raritan, NJ)
- …potential suppliers, manage RFI/RFP and term sheet development, and negotiate contracts. Lead cross-functional teams and collaborate with Quality , Legal, CMC, ... with external suppliers, while integrating internal SMEs and key stakeholders.Conduct supplier performance reviews and lead projects to improve OTIF (On Time… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... as an engineering resource for biologics operations, build strong equipment knowledge, lead projects, and provide guidance and training to operationalize the GMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. ... Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance… more
- Merck & Co. (Durham, NC)
- …cross-site issues, identify trends and participate in proactively implementing risk mitigation actions.Collaborate with functional teams to contribute to strategic ... workstreams, knowledge sharing, and process improvement projects. Lead projects through all phases including project planning, project management and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational ... design` principles in assigned clinical trials.The CQOM will develop Risk Assessment and Categorization Tools and Quality ...levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance… more
- Merck & Co. (Durham, NC)
- …issues, help identify trends, and participate in the implementation of risk mitigation actions.Collaborate with functional teams to contribute to strategic ... justifications, data analysis, process monitoring, site comparisons and technical risk assessments.Facilitate technical forums and help maintain product historical… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... internal and external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across the organization and… more
- Merck & Co. (Rahway, NJ)
- …all platforms (eg syringes, auto injectors, bottles, blisters) meet safety, efficacy, quality , and robust supply standards. Drive proactive risk management ... and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence ... analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This leader will also ensure a ... may be expected to serve as Program level Delivery Lead on large and/or complex programs, including those involving...as our Network sites) and drive the CRO to quality , cost, and shortened timelines wherever possible. The ED… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution ... analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering a… more
- Merck & Co. (Rahway, NJ)
- …on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities: Strategic Leadership and… more
- Merck & Co. (Rahway, NJ)
- …method transfers and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis.Provide sponsorship of both in-line and ... Job Description Global Quality Large Molecule Analytical Sciences (GQ- LMAS) -...and teamwork skillsSelf-motivated with a positive attitude and proven performance recordKnowledge with drug substance and drug product release,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for site's Strategic Initiatives Team.Defines the interdependent deliverables and ensures that quality , risk , cost, time are managed within the overall approved ... its application to drug product manufacturing required to deliver time, cost, quality , and risk management to teams.Experience with Healthy Authority… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cGMP manufacturing experience preferred.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to ... team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy manufacturing processes. This role… more
- Merck & Co. (Rahway, NJ)
- …inputs, outcomes, risks, and enterprise-wide prioritization. Primary Responsibilities include: Lead a sterile product group, accountable for people and operations, ... development core deliverables. - Provide leadership in areas of problem solving, risk identification and mitigation, and scenario planning in support of teams… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project plans across functional teamsDefines the interdependent deliverables and ensures that quality , risk , cost, time are managed within the overall approved ... discipline and its application to drug development required to deliver time, cost, quality , and risk management to teams.Demonstrated results in creating and… more
- Merck & Co. (Rahway, NJ)
- …assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience supporting/writing ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (North Wales, PA)
- …strategic acumen, and execution, along with leadership skills to lead complex cross functional projects.Essential Duties and Responsibilities:The engineer will ... leverage their scientific, technical, and business expertise to participate or lead in capital equipment projects, developing network equipment & process standards,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversee the development and promotion of the 6th Mid-Term Strategy for Global QA, lead the execution of the business plan, and manage resources effectively to meet ... team, developing standard approaches that foster a reputation for outstanding quality , collaboration, rigor, and follow-through. Collaborate with the Head Global RD… more
