- BioAgilytix (Durham, NC)
- …Minimum SkillsAbility to execute on all technical aspects of data integration, automation, and quality independently, handling complex data ... a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build … more
- Merck & Co. (Rahway, NJ)
- …and IT functions, and develop strategic digital roadmaps, and lead delivery of capital project digital programs.Responsibilities include:Planning and allocating ... CMC business area in DSCS and Commercialization.- Familiar with the interdependence of data flows and engagement on projects across the AR&D (Analytical R&D) , PR&D… more
- Novo Nordisk Inc. (Durham, NC)
- …Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...practices, to include increasing awareness of data management standards & validation to create improvements in… more
- Aequor (Houston, TX)
- …on-site 5x/week Responsible for tracking, management, and completion of Supply Chain Quality Records (such as deviations, material recalls, and CAPA) in partnership ... improvement initiatives based on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I, for the Warehouse… more
- Formation Bio (New York, NY)
- …seeking a hands-on technical leader to shape the future of our Data Platform. This role is ideal for someone passionate about building scalable infrastructure at ... the intersection of data engineering and applied AI. You'll lead ...and transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation ... meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for...Leads and Technical Leads to ensure validation and technical … more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees… more
- Twist BioScience (South San Francisco, CA)
- …solutions across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated ... GxP regulations, industry best practices, and technological advancements in biotechnology . Technical Team Management: Lead , mentor, and develop a high-performing… more
- Merck & Co. (Durham, NC)
- …your engineering expertise and leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Merck & Co. (Durham, NC)
- …performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will be required based on business ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Merck & Co. (Durham, NC)
- …sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times, ... problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and approve out of tolerance (OOT) records… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise in supporting RBQM activities.- Technical : Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality ... levels and from different disciplines and cultures. Must have technical knowledge on integrated data review and... Surveillance, targeted source document verification and targeted source data review. Lead the team to develop… more
- Merck & Co. (Rahway, NJ)
- …of a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and ... Job DescriptionWe are seeking a strategic and technical leader with expertise in cell culture commercialization. The primary objective of the Biologics Drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and secondary data analytics. Incumbent must have the knowledge and technical skills to do this across a brand's lifecycle including pre-launch, launch, growth, ... assessment of available data and determination of knowledge gaps c) translating data into insights with business impact Lead development of assigned market… more
- Insmed Incorporated (San Diego, CA)
- …a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations ... Involves hands-on laboratory work, analytical procedure optimization, troubleshooting, and data analysis and collaboration with all process development teams to… more
- Merck & Co. (San Francisco, CA)
- …execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is ... safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness… more
- Merck & Co. (Upper Gwynedd, PA)
- …include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory ... of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global product and project regulatory… more
- Insmed Incorporated (San Diego, CA)
- …Department, supporting clinical GMP drug substance and drug product production and quality control operations. This role combines technical leadership in ... inventory and calibration standards. The individual will collaborate closely with the technical operations and quality teams to develop and implement robust… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Metrology Technician I/II as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be ... Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production… more
