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o 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.
o Will be required to prepare solutions and medias and perform required in-process testing.
o Will be required to set-up, operate and clean/sterilize small and large scale bioreactors as well as cell harvesting equipment on a daily basis.
o May 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.
o Responsible for Batch Data Records, notebooks, customer reports and work order documents.
o 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.
o 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.
o Identify potential issues in the production process; report findings to team management and members for resolution or participate in troubleshooting.
o May perform other related duties as required and/or assigned.
o Complying with all company safety regulations and procedures and report non-compliance.
o Serving as an effective safety steward by ensuring accurate reporting of near misses and attending safety trainings
o Knowledgeable of SDS for relevant products
o Operating a safe work environment through continuous safety awareness and full compliance to all EH&S programs and activities.
Minimum Education/Experience Requirements:
o Must have a bachelor's degree in Biology, Microbiology, Bacteriology, Cell Biology, Chemistry, Biochemistry, or other related discipline.
o Experience in the application of cellular or microbiology laboratory techniques in an academic, manufacturing or research laboratory is preferred.
o Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials required. Some experience in the use of basic laboratory techniques; i.e. buffer preparation, protein and nucleic acid gel electrophoresis, cloning with bacterial transformation, aseptic technique and DNA sequencing analysis is a plus.
Preferred Skills and Attributes:
o Consistent, dependable and accurate in carrying out responsibilities
o Displays positive attitude toward job and others
o Follows and provides direction accurately and efficiently
o Excellent documentation and communication skills
o Demonstrated ability to carry out scientific procedures and make recommendations for improvement required.
o Good problem solving skills necessary.
o Working knowledge of manufacturing related computer software preferred.
o Intermediate Excel skills
o Works in both a lab environment and manufacturing facility with specialized equipment.
o Employees may be required to operate automated and semi-automated equipment.
o Lifting up to 25 lbs will be required on a frequent basis.
o May be required to stand for long periods of time while performing duties.
o Must be flexible to work varying schedules and hours as needed.
o Must be able to work safely with chemicals and hazardous materials.
o The noise level in the work environment is usually moderate.
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