Laboratory Operations Expert

2 weeks ago

Temecula, California, United States GTT, LLC Full time
Laboratory Operations Expert
Contract Duration 12 Months
Pay range $20 - $25/hr

Job Description
Successful manufacture of products

Perform bulk laboratory operations such as fractionation of antiserum, dialysis, filtration, labeling, and bottling, using available resources to coordinate daily manufacturing requirements.

Perform various testing methods such as Heidelberger titers, total protein, OD280, IEP, and SDS-Page
On-time Manufacture of products as needed per the Planning department
Perform standard and new operating procedures
Execute complex laboratory methods per established procedures; support activities to resolve process and testing issues under the guidance of senior staff
Perform procedures involving calculations and material measurements.
Collect and evaluate data per defined specifications
Safely and correctly operate standard laboratory equipment
Prepare routine solutions and reagents
Utilize software for data entry and recordkeeping 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)
Execute objectives and planned schedules as outlined by the supervisor
Train other lab personnel in established procedures
Filling, labeling, and packaging of products
Contribute to the 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

Problem-solve Manufacturing-related issues:
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 the direction of team management, including revising SOPs

Improve manufacturing processes:
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 new product development:
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

Education & Experience:
A bachelor's degree in a Life Science discipline with related experience is preferred.
In lieu of a Bachelor's degree in a Life Science discipline, a minimum of 5 years of specific and demonstrated experience may be considered
Basic knowledge in the use of laboratory techniques such as sterile and aseptic techniques, buffer, and large- and small-scale protein purification

Knowledge, Skills & Abilities:
Demonstrated knowledge in the use of basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, filters, microscopes, BioSafety Cabinets, and centrifuges
Demonstrated knowledge in Sterile / Aseptic technique required
Demonstrated knowledge of cell culture techniques is required, as well as a basic knowledge of antibody and protein production methods
Demonstrated ability to follow directions outlined in Standard Operating Procedures; ability to accurately complete Batch Records while adhering to Quality and Regulatory requirements
Basic knowledge of cell-based assays, and basic immunological/molecular techniques
Ability to properly and safely handle biologically hazardous materials
Working knowledge of manufacturing ERP systems, Oracle or SAP preferred
Good computer skills with proficiency in Office 365 and Excel software applications
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 to 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 circumstances and to thrive in a constantly changing business environment
Demonstrated knowledge of laboratory safety plans and procedures to ensure compliance with applicable federal, state, and local regulations
Self-directed and self-motivated with the ability to work independently as well as in a team environment

Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund

About The Company:


Our client aspires to be the premier research-intensive biopharmaceutical company by using the power of leading-edge science to save and improve lives around the world.

For more than 130 years, they have brought hope to humanity by developing important medicines and vaccines.

Today, they are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Our client fosters a diverse and inclusive global workforce and operates responsibly every day to enable a safe, sustainable, and healthy future for all people and communities.

#gttnonit

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