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Position Summary:
Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.
location: Berkeley, California
job type: Contract
salary: $30.00 - 37.48 per hour
work hours: 8 to 4
education: Bachelors
responsibilities:
- Prepares process equipment (including but not limited to Bioreactors & ancillary equipment, Stainless Steel tanks, Pressure Transmitters, Flow Meters, Aggregate traps, Harvest discards, Transfer lines (buffers, cTCF), Hoses and small parts.
- Cleans and Sterilizes equipment using appropriate CIP (Clean-In-Place), SIP (Steam-In Place) procedures.
- Performs daily or routine process operations in the cell culture and purification of biotech and biological products (Kovaltry, Kogenate, and Jivi). Operates equipment for these processes including:
- Inoculates and monitors bioreactors.
- Processes cTCF material to Continuous Cell Separation (CCS).
- Operates Chromatography, MAEF, MAVF and TFF skids.
- Processes MAEF material using closed thaw process, step elution chromatography,
- Membrane Absorber and filter clearance technology, and gradient controlled SP column separation techniques.
- Operates 50L, 200L and 1000L collection bag technology to ensure robust collection, mixing and dilution of products.
- Performs PEGylation of JIVI in process material using TFF technology.
- Operates automated bagging systems.
- Blast Freezes product for storage.
- Dispenses chemicals and formulate solutions.
- Prepares acids and bases as necessary.
- Performs aseptic operations.
- Takes, analyzes and submits samples as required throughout the process.
- Monitors and controls operation with computer control systems.
- Completes all routine check sheets.
- Cleans equipment and maintains clean and orderly production facilities.
- Performs in-depth troubleshooting and root cause analysis of Kovaltry, Kogenate, and Jivi equipment and process failures.
- Contributes to continuous improvement opportunities.
- Performs all operations in compliance with cGMP.
- Performs other related duties as assigned.
qualifications:
- Requires completion of two-years' college science courses in (e.g. biology, chemistry, biochemistry, or microbiology) or a certificate from an accredited bio-technology academy.
- Relevant bio-tech industry experience in some or all of the following is preferred, and may be considered in lieu of some or all of the educational requirements above
- Cell Culture bioreactor system assembly and use, including control of gas supply to bioreactor, Micro-sparger assembly, Anti-Foam Emulsion system. Ability to troubleshoot and control processes.
- Continuous Cells Separation equipment preparation and process/controls.
- Membrane Absorption Chromatography process (e.g. Membrane Absorption process, Buffer and NaOH supply, cTCF supply, Capsule preparation, Inline dilution and Temperature controls).
- Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.
- Membrane Absorber technology, viral removal techniques and tangential flow filtration technology. Large scale chromatography, TFF technology.
- Familiarity with cGMP's and applicable agency regulations
skills: Cell Cultures, GMP (Good Manufacturing Practice), Manufacturing Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
