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Validating high complexity lab test methods

The individual applies basic knowledge form various technical areas, industry practices and standards under close supervision.

This position is focused on the downstream portion of the biologicsmanufacturing of Obizur, an FDA-approved treatment for Acquired Hemophilia A.Responsibilities include designing experiments per ICH guidelines, flawless execution of experimental studies, documenting results accurately in the laboratory notebooks, writing and reviewing technical reports, generating test methods to support high throughput and QC testing groups, participate in analytical, process development and QC meetings and discussions, etc.Seeking an Engineer II with the following duties: Act as key member of the Massachusetts process lab, part of the PDTS (Process Development and Technical Services) organization; execute product lifecycle and manufacturing support for global biologics network; emphasize hands-on, lab-based activities to design and execute studies to support late phase clinical and commercial manufacturing; The individual will be a member within a group responsible for performing purification process development, including timely completion of small-scale experiments and process scale-up for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases.The instructor will consult with the lead instructor for the course and follow syllabus and the case-based format.They will be responsible for writing and grading exams and other assignments.Some metals species are present as oxy anions such as arsenite.

Most regulations use total metals results because it is often considered more conservative and protective, however, depending on the purpose of the regulation it might be based on dissolved or total metal concentrations.

Cross-training in the upstream (cell culture) aspect of the manufacturing process is also part of the job but primary responsibility is for executing all purification steps in production process while strictly adhering to c GMP, environmental health and safety guidelines and any other related regulations which apply.

Works as part of the team to partner with manufacturing in troubleshooting the automated control processes.

This versatile role will support the day-to-day laboratory operations that are the key to successful research and manufacturing processes.

The applicant will be advised by and work directly with Ultivue’s Research and Development team The successful candidate will be able to perform duties with some supervision and will collaborate within the group and across other core lab functions. The successful candidate will be energetic, efficient and thrive in a fast-paced environment.

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