- 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)
- …role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication… 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
- 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
- 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
- Aequor (Waltham, MA)
- Title: Research Associate/ Sr . Research Associate Contractor, Capsid Engineering - NGS Location: Waltham, MA Position Overview: 's Genomic Medicine Unit based in ... with possibility of extension. Key Tasks & Responsibilities: Support and lead the implementation of next-generation sequencing techniques to characterize plasmid/… 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
- 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
- Merck & Co. (Rahway, NJ)
- …development and commercialization teams, partner functions including Global Science Engineering and Commercialization (GSEC), Quality , and CMC Regulatory ... commercializing and supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head of Global… 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
- Merck & Co. (Durham, NC)
- …vaccine manufacturing facility in Durham, North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate ... strong individual and has the ability to communicate effectively with senior management on complex technical issues and manage multiple high-priority, complex… more
- Merck & Co. (Durham, NC)
- …experience in Biopharmaceutical industry across multiple manufacturing disciplines (Operations, Quality , Technology, Engineering , Supply Chain, etc.).-At least ... Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability… more
