Associate Manufacturing Scientist

Work Location:

Temecula, California

Shift:
Department: LS-SC-UWTPA Antibodies
Recruiter:
Ashley Hennessy

The Associate Manufacturing Scientist will perform routine laboratory operations associated with the manufacture and packaging of cell culture media and reagents for Life Science business unit resulting in customer satisfaction.

• On time Manufacture of products as needed per Planning department
• Perform standard and new operating procedures
• Execution of complex laboratory methods per established procedures. Support activities to resolve process and testing issues under guidance of senior staff
• Perform procedures involving calculations and material measurements. Collect and evaluate data per defined specifications
• Operating standard laboratory equipment
• Preparation of routine solutions and reagents
• Utilize software for data entry and record keeping in conformance with company and regulatory policies and standards
• Ensure compliance with all quality and regulatory specifications
• Execute the manufacturing performance metrics (productivity, customer satisfaction and quality improvements)
• Train other lab personnel in established procedures
• Filling, labeling and packaging of products
• Execute on objectives and planned schedules as outlined by supervisor
• Contributes to completion of specific programs and projects
• Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations
• Develop, write and update documents pertaining to lab procedures and product manufacturing to maintain cGMP and/or ISO compliance
• Actively participate in troubleshooting and the identification of manufacturing and production issues.
• May assist with the research of new methods or steps in a process at direction of team management, including revising SOPs
• Identify inefficiencies and opportunities for process improvements
• Assist in the implementation of manufacturing procedures intended to optimize existing processes, such as yield, time and cost, and ensure achievement of regulatory and customer requirements
• Support R&D and Tech Transfer functions in bringing new products to manufacturing
• Train on new SOPs, technologies etc. to support the manufacture of new products

• High School Diploma or GED with 5+ years’ experience lab experience

OR

• Bachelor’s Degree in a Life Science discipline (Biology, Chemistry, Botany, etc.)

• Basic knowledge in the use of laboratory techniques such as sterile and aseptic techniques, buffer/media preparation, cell culture, large- and small-scale protein purification, and Western Blotting
• Capable of following directions outlined in Standard Operating Procedures, ability to accurately complete Batch Records while adhering to Quality and Regulatory requirements
• Demonstrated knowledge in the use of basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, filters, cell counters, microscopes, CO2 incubators, Bio Safety Cabinets and centrifuges
• Demonstrated knowledge in Sterile / Aseptic technique
• Demonstrated knowledge in cell culture techniques is required, as well as a basic knowledge of antibody and protein production methods
• Basic knowledge in western blot, cell-based assays and basic immunological / molecular techniques
• Ability to handle biologically hazardous materials
• Working knowledge of manufacturing ERP systems, Oracle or SAP
• Good computer skills with proficiency in Microsoft Word and Excel software programs
• Ability to solve simple and complex mathematical equations
• Ability to multi-task and meet manufacturing production schedules with a sense of urgency
• Good organizational skills and attention to detail
• Good verbal and written communication skills including the ability create clear, concise written reports and accurate completion of batch records
• Ability to follow, write, and edit Standard Operating Procedures
• Adherence to Quality and Regulatory requirements/programs
• Ability to adapt to rapidly changing business circumstance and to thrive in a constantly changing business environment
• Demonstrated knowledge in laboratory safety plans and procedures to ensure compliance with applicable federal, state and local regulations
• Sel…