- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This… more
- Merck & Co. (Upper Gwynedd, PA)
- …all assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for ... milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures.- Lead development and… more
- BioAgilytix (Durham, NC)
- …to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs and implement initial quality checks independently, ... diagnosing data challenges and designing innovative solutions to improve data quality , integration, and regulatory adherence.Capable of growing with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory complianceEnsures that Data Management ... global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… 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 ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Tris Pharma (Monmouth Junction, NJ)
- …has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees ... and manages the Quality Assurance (QA) Investigations and Product Quality ...(OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and… 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 ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams… more
- Merck & Co. (Rahway, NJ)
- …collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of ... execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for… more
- Insmed Incorporated (San Diego, CA)
- …for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating ... (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe...techniques and instrumentation is necessary, as is knowledge of regulatory guidelines like cGMP and ICH, and data… more
- Formation Bio (New York, NY)
- …role in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and ... and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing… more
- Merck & Co. (Durham, NC)
- …Substance/Product start-up experienceDemonstrated experience of interacting with site, divisional or regulatory auditsCore Skillsets Ability to develop and lead ... 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)
- …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 ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.The Sr. Specialist, Calibration… more
- Merck & Co. (Rahway, NJ)
- …Methodologies (separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Insmed Incorporated (San Diego, CA)
- …and execute C&Q plans in compliance with internal procedures and regulatory standards. Lead CMMS implementation and maintenance, including asset setup, ... supporting clinical GMP drug substance and drug product production and quality control operations. This role combines technical leadership in equipment lifecycle… more
- Genmab (NJ)
- …of high- quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft scientifically ... part of a dynamic, collaborative team that values innovation, quality , and scientific integrity? At Genmab, we are seeking...the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a… more
- Merck & Co. (South San Francisco, CA)
- …Sciences, Pharmacology, Pharmacometrics, PKPD Modeling, Population Pharmacokinetics, Quality Management, Regulatory Applications, Stakeholder Relationship ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… 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
