Biologist II

Biologist II#26-13513 $35.45-$37.74 per hour Irvine, CA

All On-site Job Description Job Description:

The PDS&T Toxins group within Operations Science & Technology - Biologics organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxins products in Client. We have an exciting opportunity for a Biologist II/III position based in Irvine, CA. The candidate's primary responsibilities will include but are not limited to the production, testing, inventory, and supply of Master, Working, and development cell banks for clinical, and commercial production as well as analytical and bioassay testing. The candidate should be experienced in standard cell culture, biochemistry, and molecular biology techniques and is expected to clearly communicate the scientific rationale, methodology and results in written and oral formats. Execute production, testing, and release of Master, Working, development, and analytical cell banks and ensure the timely supply of customers Perform cell culture and cryopreservation of cells using aseptic techniques under GDP and GMP compliant conditions Performing routine quality checks on cell cultures, including sterility testing, mycoplasma detection, genetic stability analysis, and functional bioassay. Identifying and resolving issues related to cell culture, such as contamination, cell detachment, or abnormal growth patterns. Interface with internal and external customers to ship cell banks and supply critical information as per their requirements. Accurately document, critically analyze/interpret data and communicate the results promptly through various electronic means Understand and adhere to corporate standards regarding code of conduct, safety, and appropriate handling of materials Author, review, and approve technical documents, SOPs, and batch records. Availability to work occasional weekends as needed Must be comfortable with physical activities of constant standing, walking, and sitting with arm stretching into biosafety cabinets for cell culture work Qualifications

Biologics II:

BS or equivalent education with typically 3 or more years of experience or MS or equivalent education with typically 1 or more years of experience.

Biologics III:

BS or equivalent education with typically 5 or more years of experience or MS or equivalent education with typically 3 or more years

Skills:

Hands-on experience in cell culture and aseptic techniques, including media preparation, cell culture optimization, cell passaging, and cell banking Able to maintain the instrumentation, inventory and cleanliness of a developmental lab to create a safe, effective and efficient scientific working environment. Data analysis and interpretation skills Excellent documentation and record-keeping abilities Work in a team environment as well as contributing individually to meet project timeline and objectives. Excellent communication, writing and presentation skills are required. Must have a "results-oriented" work ethic and a positive "can-do" attitude with a strong sense of urgency and self-motivated desire to achieve. Demonstrated knowledge of GDP and GMP experience Proficient with but limited to the following key technical skills: mammalian cell culture, familiarity with cell culture instrumentation (cell counters, microscopes, centrifuges, cryopreservation systems), cell-based bioassays, qPCR, sterility testing, and mycoplasma detection. Experience in performing routine quality checks on cell cultures, including, qPCR, cell-based bioassays, sterility, and mycoplasma detection Excellent documentation and record-keeping abilities Must have a "results-oriented" work ethic and a positive "can-do" attitude with a strong sense of urgency to meet project timeline and objectives. BS or MS degrees in a relevant scientific discipline

Additional Information:

This position requires the individual to work in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with client internal and applicable regulatory requirements. Client internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives