- Merck & Co. (Durham, NC)
- …DescriptionJoin our dynamic Engineering , Maintenance, & Utility Department as a Senior Specialist, where you will play a crucial role in enhancing asset ... the highest quality of raw materials, intermediates, and finished products.The Sr . Specialist, Calibration Engineer is a member of the Engineering ,… more
- Twist BioScience (South San Francisco, CA)
- Sr . Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing ... Execution System (MES) Director to lead the strategic development, implementation, and optimization of our...our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated… more
- Merck & Co. (Rahway, NJ)
- …Engineering ). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... Job DescriptionThis Senior Engineer position will provide engineering ...Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE)… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and ... compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 tasked ... that: Attracts and cultivates essential skills needed for data & AI Engineering , GenAI development, and analytics automation and dashboarding, ensuring the team… more
- Merck & Co. (Rahway, NJ)
- …activities with the clinical, regulatory, formulation, commercial and other key company functions. Lead the Device Engineering Sub-Teams focused on development of ... administration including inhalation, implantation, and injection.--This position serves as a senior individual contributor who will be responsible for applying deep… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 statisticians, ... 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… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ... in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and execute… more
- Formation Bio (New York, NY)
- …for someone passionate about building scalable infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and transform ... unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and decision-making across the company.… 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 ... based in Waltham, MA and will report to the Sr . Director, Quality - Quality ...for monthly KPI's and management review meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Beckman Coulter Diagnostics (Miami, FL)
- … initiatives into sourcing decisions and long-term supplier strategies.Independently lead quality workshops and comprehensive supplier development initiatives ... with 9+ years of experienceMinimum 10 years' experience in supplier quality engineering or supplier development within international manufacturing… more
- Merck & Co. (Upper Gwynedd, PA)
- …Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/ Sr Principal Scientist in Pre-approval Pharmaceutical ... 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… more
- Cytiva (Pensacola, FL)
- …experience, with senior leadership roles in QA, Operations, or Quality Engineering preferred.Regulatory and Quality Expertise: Strong knowledge ... development, psychological safety, and continuous improvement.Audits, Reporting, & Representation: Lead Quality Management Reviews, define and monitor KPIs,… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations. The ideal candidate will have strong ... strategies that ensure compliance with GxP (as applicable) and other regulatory requirements. Lead the operation of the site BAS and HVAC control systems. Manage… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... Nordisk and help us make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will… more
- Merck & Co. (Rahway, NJ)
- …ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation and/or ensure effective execution of the ... / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials for program presentations for management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of commercial and clinical capacity.Build strong partnerships with Manufacturing, Supply Chain, Engineering , MS&T, and Quality to ensure seamless execution of ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Aequor (Thousand Oaks, CA)
- …B20 plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering . A high degree of interactions and ... and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network… more
