- Merck & Co. (Rahway, NJ)
- …and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work ... and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control /QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am EST - ... 4:30 pm EST.The Document Control /QA Associate I will report directly to the QA/QC...to meet established deadlines (paper and electronic).Maintains related database systems , if applicable, logs and complete forms/records as required.Adheres… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Farrar Corporation (Norwich, KS)
- …centers, (PLC's) programmable logic controllers, control panels, pneumatic and hydraulic systems , and electrical control systems . Primary Duties & ... with devices such as voltmeters, megohmmeter, and ohmmeters. Lead major repair projects to be completed by a...code books, and specifications Demonstrated ability to inspect electrical control systems , equipment, and machines and identify… more
- Novo Nordisk Inc. (Durham, NC)
- …in relevant areas Own self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, ... Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and… more
- Merck & Co. (Durham, NC)
- …technology transfer focusing on either upstream, downstream, and/or culture media/support systems . Off-shift and weekend coverage will be required based on business ... qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates… 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 and… more
- Boom Supersonic (Denver, CO)
- …as the technical lead for the design and development of aircraft flight control systems , you will: Lead the development, implementation, and validation ... hard problems with precision and creativity. As Principal Flight Control System Engineer, you'll lead development of...the design, analysis, testing, and certification of the flight control systems for our next-generation aircraft. We're… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems .Proven expertise in design controls, risk analysis, control … more
- Twist BioScience (South San Francisco, CA)
- …culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Aequor (Thousand Oaks, CA)
- …a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected ... Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and preventative… more
- Merck & Co. (Rahway, NJ)
- …its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the ... on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and ... characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe...also key duties. Collaboration with R&D, Process Development, Quality Control , and Regulatory Affairs is essential, as is facilitating… more
- Formation Bio (New York, NY)
- …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 ... infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and transform unstructured and structured research, biomedical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of ... review for phase III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process, product, and equipment issues… more
- Novo Nordisk Inc. (Durham, NC)
- …Belt certification or equivalent preferred. Knowledgeable in the following systems : Instrument & Electrical, Mechanical, Control /SCADA/PLCs, Process Improvement ... Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the core processes to meet all customer, business &… more
- Twist BioScience (South San Francisco, CA)
- …a proven ability to scale accounting operations, and the determination to lead the department through growth and continuous improvement.Position is Hybrid - Tuesday, ... with IT on all matters impacting the Company's general ledger and control environmentSupport the annual audit and tax complianceDevelop scalable internal controls… more
