- 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)
- …principal component analysis, etc.Develop and implement statistical process control methodologies and data anlaysis to ensure the quality and reliability of ... and processes.- It is expected that this role will lead significant investigations or events directly, and mentor and...and analysis, such as product complaints and on-going performance data , to drive deeper technical understanding and… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... for all dosage forms (liquid, lyo, drug-device combinations)Review and approval of data and technical documentsAbility to recruit, select, develop, and mentor… 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. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality… 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. (Rahway, NJ)
- …collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of ... you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a...clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading… 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. (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
- Merck & Co. (Rahway, NJ)
- …in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring ... the group Director to define group strategy and to lead a team of scientists in solving complex analytical...(separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data … 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
- Aequor (MA)
- …and data analysis, nucleic acid purification and characterization, take lead in high throughput gene synthesis and plasmid production, process automation and ... protocol development, improvement of quality and throughput, problem solving etc. Key responsibilities for...mRNA vaccine target development, DNA template production, QC and data analysis. Develop, evaluate, and implement new synthetic biology… more
