- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level...established processes.RequirementsA minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline or relevant experience is… 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 ... Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring… 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 ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Merck & Co. (Durham, NC)
- Job DescriptionJoin our dynamic Engineering , Maintenance, & Utility Department as a Senior Specialist, where you will play a crucial role in enhancing asset ... and driving manufacturing excellence in a fast-paced environment. Utilize your engineering expertise and leadership skills to empower teams, solve complex technical… 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 ... Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn,… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... Minimum Education Requirement and Experience: - Bachelor's degree in Chemical Engineering , Bioengineering, Biological Engineering , or a related field with… 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
- BioAgilytix (Durham, NC)
- …for building a high-performing data management team, identifying roles in data engineering , quality , and automation as the function matures.Sponsor Data Delivery ... That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can… 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 ... or related field - Required Master's Degree in Computer Science, Life Science, Engineering , or Information Systems - Preferred Experience10+ years of experience… more
- Novo Nordisk Inc. (Durham, NC)
- …IT or Engineering experience in process-based manufacturing, utility, &/or packaging systems required May consider a High School Diploma or equivalent with a ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...Engineering experience in process-based manufacturing, utility, &/or packaging systems required Minimum of eight (8) years of … more
- Merck & Co. (Rahway, NJ)
- …13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering , Biomedical Engineer, or a ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical… 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
- Twist BioScience (South San Francisco, CA)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and ... Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI...value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering . A high… more
- Merck & Co. (Durham, NC)
- …opportunity for you!The Associate Specialist, Calibration is a member of the Engineering , Maintenance and Site Services (EMSS) team providing support to the Durham ... sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times,… 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 ... for a builder who thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and… more
- Merck & Co. (San Francisco, CA)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build… 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
- 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …this role will be commensurate with experience. Relationships Reports to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...scale. This role will be part of a Manufacturing Engineering team providing direct support to the manufacturing floor… more
