- Lilly (Indianapolis, IN)
- …assembly or packaging operations. + Working knowledge of cGMP and Computer System Validation (CSV) frameworks + Ability to interpret process requirements and ... and validation . + 3+ years of experience in regulated pharmaceutical or medical device manufacturing environments. **Additional Preferences:** + Familiarity with… more
- Kelly Services (Rochester, MI)
- …of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and ... areas. This person is expected to write and review SOPs, test methods, validation protocols and validation reports. The Senior Scientist also provides mentoring… more
- Lilly (Indianapolis, IN)
- …American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre- validation / validation , ongoing operations ... of CMs manufacturing, Device assembly and packaging, the batch disposition process and maintenance/improvements of their quality systems. + Evaluate issues,… more
- ThermoFisher Scientific (Florence, SC)
- …Conduct routine and non-routine chemical testing and method development/qualification for pharmaceutical raw materials, in- process samples, and active ... on raw materials, samples, stability, production intermediates, and active pharmaceutical ingredients, including method development and qualification activities. Support… more
- Unither Pharmaceuticals (Rochester, NY)
- …of Engineering and Facilities Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and ... Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and the overall drug development process . + Demonstrated experience with process validation and regulatory requirements. NDA / MAA/ ANDA filing experience ... + Manages and executes activities related to drug product technology transfer, validation and process improvements to manufacturing partners. Oversees cGMP… more
- AbbVie (Irvine, CA)
- …+ Provide analytical support for process development and improvement, process characterization and validation . + Manage laboratory operations to ensure ... + Lead team in analytical assay transfer, development, optimization and validation for biological toxin products, following ICH guidelines. Focus areas include… more
- Sanofi Group (Swiftwater, PA)
- **Job title:** Vial Filling Process Owner Manager **Location:** Swiftwater, PA This is a 3rd shift position supporting Lines 6 and 9 either ** **Sun-Thursday or ... + Production management through leading, scheduling, planning, and use of all key process systems such as eOOE, iObeya, Qualipso, SAP, and Ocularis. (20%) + … more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …Operations issues, Laboratory and Manufacturing investigations, Product Specifications, Analytical Method Validation , Process Validation , Method and ... based on monitoring of trend data. + Reviews Analytical method and process development, enhancements and validation /verification, transfer related documents and… more
- Amgen (West Greenwich, RI)
- …of automation engineering principles in the design, specification, construction, startup, and validation of GMP process and utilities equipment and systems for ... process engineering, utility operations, maintenance, quality assurance, and validation to manage a diverse portfolio of projects + Provides technical… more
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