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Process Development Associate - #10
The Woodlands, TX
Job Description
Job Summary:
This individual will conduct a variety of cell culture and analytical assays in support of product characterization and potency assessment. The position will also participate in process development, optimization, validation, and tech transfer to GMP.
Job Description:
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
This individual will conduct a variety of cell culture and analytical assays in support of product characterization and potency assessment. The position will also participate in process development, optimization, validation, and tech transfer to GMP.
Job Description:
- Work under the supervision of the Senior Scientist to execute multiple laboratory procedures such as cell culture (aseptic technique), separation of blood components, cell counts, determination of cell viability, proliferation assays, cytotoxicity assays, ELISA, ELISpot, Luminex assays for cytokine detection, and multi-color flow cytometry testing.
- Contribute to process development activities including development, optimization, and qualification of Cell Therapy processes. Participate in the transfer of processes to GMP staff, as appropriate.
- Interpret and follow standard operating procedures and execute activities in accordance with cGMP, GLP, regulatory, and safety requirements as directed. Independently trouble-shoot and report to the Senior Scientist.
- Produce high quality documentation of processes and instrumentation. Analyze data and report results according to established policies and procedures.
- Evaluate new technologies and protocols and report results. Monitor programs to ensure the accuracy of tests.
- Participate in organization, supply maintenance, and recordkeeping duties as needed to support the laboratory. Able to react to change productively and handle other essential tasks as assigned.
- B.S. degree in the Life Sciences (biology, immunology, medical technology) AND at least 3 years of experience in a laboratory environment or M.S. and minimum of 1 year of experience in an FDA-regulated environment in the field of Cell therapy, working in either manufacturing or process development.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Job Summary
Company
Employment Term and Type
Regular, Full Time
Salary and Benefits
Competitive
Required Education
Bachelor's Degree
Required Experience
3 to 5 years
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