Senior Manufacturing Technician

Summary

A Senior Manufacturing Technician is responsible for manufacturing products to meet or exceed customers' specifications according to SLI manufacturing procedures, adherence to the SLI Quality System, and compliance to the FDA/ISO and GMP guidelines, with minimal supervision. This employee is required to assist the lab manager with production improvement, process troubleshooting, and new product development. In addition to regular production activities, this employee also is required to participate in antiserum characterization, antibody performance evaluation, immunogen preparation, new antibody development, therapeutic manufacturing and other production and research related projects. The role requires critical thinking, accurate execution of SOPs, MMPs, recognition of abnormal analytical trends, strong documentation practices, and proactive identification/ escalation of manufacturing concerns.

Responsibilities

• Polyclonal antibody purification
• Immunoaffinity protein purification
• Ion exchange purification
• Antiserum characterization
• Involve heavily in K2 Ascites productions in Bulk
• Evaluate and select appropriate raw material and/or starting material for productions or filling orders according to specification.
• Expected to improve laboratory efficiency, improve time for results, reduce costs, improve inventory control, etc.
• Review manufacturing documents for Bulk production for clarity and completeness
• Update the percentage yield for Bulk production for QMR
• Meet with Manager to communicate status of ongoing projects to ensure efficiency and accuracy
• Review and complete product packets for final release
• Capable of lifting up to 50 lb.
• Regular, reliable and predictable attendance.
• May perform other job related duties as assigned.
• May be assigned to any Scantibodies location for any period of time.
• May be required to perform other duties as assigned by supervisor. This may include duties in another department or outside your normal scope of work.

Requirements

• Bachelor's degree in Life Science or Chemistry with at least 5 years of hands-on experience in laboratories, preferably in an industrial setting
• Knowledge and bench experience in protein chemistry
• Strong experience with protein purification techniques, including column chromatography, Ammonium Sulfate Precipitation, DEAE, Protein A, G, A/G, L, Affinity Chromatography, Ligand Attachment Chemistry, Dialysis
• Experience with analytical techniques, including HPLC, UV-Vis spectroscopy, SDS-PAGE, conductivity, and pH
• Excellent buffer formulation skills
• Competitive job performance in quality antibody purification and troubleshooting
• Experience with downstream processing for monoclonal and polyclonal antibodies and other biologics
• Familiarity with cGMPs and ISO regulatory requirements for biopharmaceutical production
• Basic training in production management
• Excellent communication skills
• Organization and leadership skills
• Experience with lyophilization is desired
• Bi-lingual speaking, reading and writing Spanish is desired.
• Valid driver’s license, current proof of insurance and clean driving record

Job Benefits

We offer a comprehensive benefits package to include paid sick, vacation, medical, dental, vision, life insurance and 401(k).

Contacts

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Scantibodies Laboratory, Inc. is located at:

10946 Woodside Avenue North, Santee, CA 92071