- Takeda Pharmaceuticals (Cambridge, MA)
- …and maintain advanced process models and digital twins that drive control and optimization strategies across manufacturing processes, both for unit-operations and ... support tech transfers, and strengthen overall process capability and product quality . **How you will contribute** + Develop mechanistic, hybrid, and statistical/ML… more
- Astellas Pharma (Sanford, NC)
- …for drug substance; and assist in the technical transfer of processes from small/ lab scale to large/commercial scale and from external partners. The role is also ... collaboration with Manufacturing, Automation, Supply Chain, Warehouse, Technical Development, Quality , Regulatory, Facilities, Validation, and various vendors. This role… more
- Actalent (Davie, FL)
- …control + Environmental monitoring + Aseptic and low-bioburden handling practices + Quality control and documentation + Plating and sterilization techniques + ... Knowledge of FDA and cGMP regulations + Strong data integrity mindset Additional Skills...or GMP environments preferred. + Exposure to pharmaceutical manufacturing, quality , validation, or laboratory operations is a… more
- Actalent (Muskego, WI)
- …+ Promote and adhere to GMPs within the facility. Essential Skills + Experience with quality control and quality assurance in food manufacturing. + Knowledge ... electronic WMS system accordingly. + Conduct basic food safety, cGMP , and quality -related training for new hires....manufacturing plant, with a balanced work environment of 50% laboratory and 50% floor. The position involves a comprehensive… more
- Fresenius Medical Center (Concord, CA)
- …understanding of current ISO 13485 standards as well as familiarity with Good Laboratory Practices (GLP) and FDA Quality System Requirements, medical device ... within the area of responsibility. * Is knowledgeable and current on SOPs, cGMP , ISO Standards (EN ISO 13485), US Regulations, Canadian Regulations, and other… more
- Actalent (Oak Creek, WI)
- …+ Conduct facility environmental testing and promote GMP practices. Essential Skills + Quality control and assurance expertise. + Knowledge of GMP, HACCP, SQF, ... the electronic WMS system. + Conduct basic food safety, cGMP , and quality -related training for new hires....dynamic food manufacturing plant with a 50/50 split between lab and floor work. Training will be provided for… more
- Kelly Services (Burlington, NJ)
- …ensure adherence to FDA and other regulatory frameworks. You'll collaborate closely with Quality Assurance, Quality Control , and Manufacturing teams, and be ... **Key Responsibilities** + Develop and implement compliance programs centered around cGMP operations. + Conduct regular assessments and audits for internal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for pre-pivotal (Toxicology, Phase I/II) biologic molecules. Identify molecule critical quality attributes, propose and justify analytical control strategies, ... and strategic input. + Provide technical support to internal and external cGMP manufacturing operations. + Presents research findings and recommendations to senior… more
- Fujifilm (Holly Springs, NC)
- …corrective maintenance to all site equipment, systems, process measurement and control , utility, laboratory , and bench-top instrumentation + Performs ... and protocols to ensure compliance with safety and Good Manufacturing Practices ( cGMP ) quality standards + Provides input and recommendation for written… more
- BeOne Medicines (Pennington, NJ)
- …of capital projects at BeOne sites on time, on budget, and with quality . This position requires close collaboration with cross-functional teams (eg, R&D, WPS, GTS, ... types include but are not limited to greenfield and renovations of laboratory , office, manufacturing, utilities, and site infrastructure. This a role reporting… more