9 senior specialist ii bioassay jobs found

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...

Responsibilities and Authority: Summary: The Sr Specialist II, Bioassay, reports to the Sr Manager, Bioassay, and will be responsible for leading and performing CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals.  In addition, the Sr Specialist II, Bioassay will be responsible for: Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria. Leading troubleshooting, method transfer, qualification and validation for complex biologic QC procedures under CGMP. Performing testing in support of product release, in-process testing, stability and characterization. Preparing SOPs, test methods, protocols and reports. Participating in laboratory administration, including Out of Specification and non-conformances arising, progression of change...