San Diego Metro Area, CA
Work in a team based environment to perform all tasks related to the production and qualification of E. coli/Pichia cell paste for use in downstream protein/nucleic acid purification.
Use large scale fermentation equipment, including but not limited to, SIP bioreactors, CIP skid and continuous flow centrifuge.
* Responsible for manufacturing product(s) in a lab setting following standard operating procedures. Will utilize basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products.
* Will be required to set-up, operate and clean/sterilize large scale bioreactors and cell harvesting equipment on a daily basis.
* Will perform cell paste qualification through use of small scale protein/nucleic acid purification techniques. Will also utilize restriction digest, DNA sequence analysis and gel electrophoresis.
* Responsible for Batch Data Records, notebooks, customer reports and work order documents.
* Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters. Advise manager of factors that may affect quality of product. Suggest options/ideas for corrective actions.
* Maintain equipment, product inventories and related records as assigned. Note variances on manufacturing documents; audit and evaluate process documents and propose revisions. Complete, distribute and file records as required in accordance with Document Control Practices.
* Identify potential issues in the production process; report findings to team management and members for resolution or participate in troubleshooting.
* May perform other related duties as required and/or assigned. Safety:
* Complying with all company safety regulations and procedures and report non-compliance.
* Serving as an effective safety steward by ensuring accurate reporting of near misses and attending safety trainings
* Knowledgeable of MSDS for relevant products
* Operating a safe work environment through continuous safety awareness and full compliance to all EH&S programs and activities.
* Must have a bachelor's degree in Biology, Chemistry, Biochemistry, or other related discipline.
* Requires a minimum of 1 year experience in the application of cellular or micro biology laboratory techniques in a manufacturing or research laboratory.
* Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials required. Experience in the use of basic laboratory techniques, including buffer preparation, protein and nucleic acid gel electrophoresis, cloning with bacterial transformation, aseptic technique and DNA sequencing analysis is desired.
Preferred Skills and Attributes:
* Consistent, dependable and accurate in carrying out responsibilities
* Displays positive attitude toward job and others
* Follows and provides direction accurately and efficiently
* Excellent documentation and communication skills
* Demonstrated ability to carry out scientific procedures and make recommendations for improvement required.
* Good problem solving skills necessary.
* Working knowledge of manufacturing related computer software preferred.
* Intermediate Excel skills Working Conditions:
* Works in both a lab environment and manufacturing facility with specialized equipment.
* Employees may be required to operate automated and semi-automated equipment.
* Lifting up to 25 lbs will be required on a frequent basis.
* May be required to stand for long periods of time while performing duties.
* Must be flexible to work varying schedules and hours as needed.
* Must be able to work safely with chemicals and hazardous materials.
* The noise level in the work environment is usually moderate.