Clinical and Health - Scientist II, Manufacturing - Cogent Infotech Corporation
Carlsbad, CA 92008
About the Job
Job Description:
- Work in a team-based environment and perform antibodies purification for use in research and commercial scientific products for the life sciences industry.
- Experiments are performed following controlled protocols and data is recorded on batch records following good documentation practices.
- Responsible for manufacturing of 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 perform purification using AKTA, HPLC, and in process testing through SDS-Page.
- 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 qualification process; report findings to team management and members for resolution or participate in troubleshooting.
- May lead process improvement projects.
- Complete, distribute and file records; prepare ad hoc reports as requested.
- May perform other related duties as required and/or assigned.
- Advise the team lead/manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials, and suggest options and ideas for corrective actions and preventive actions (CAPA).
- Bachelor's degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline and 2+ years of experience in a manufacturing or research laboratory.
- Plus: Masters. Degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline and some experience in a manufacturing or research laboratory.
- Experience in the use of scientific laboratory techniques, equipment and materials that includes some of the following techniques: AKTA purification of antibodies, SDS-page testing, HPLC analysis.
- Ability to carry out scientific procedures and make recommendations for improvement.
- Excellent documentation and communication skills.
- Displays positive attitude toward job and others.
- Regularly required to lift up to 20 pounds.
- May be required to lift weight of 45 pounds or more, with assistance and/or with equipment on occasion.
- Must be flexible to work varying schedules and hours as needed.
- Must be able to work safely with chemicals and hazardous materials.
- May be required to stand for long periods of time while performing duties.
- May intermittently sit at desk/lab bench for a long period of time to perform experiments, write, and use a keyboard to communicate through written means.
- Ability to work independently/in a group setting with direct supervision.
- Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
- Experience in ISO 90001, ISO 13485 and/or GMP manufacturing environment. Good problem-solving skills.
- Expected first shift hours are Monday through Friday 8:00 AM - 4:00 PM excluding lunch time.
- 1 teams interview Executing through Workorders.
- Antibodies purification experience a big plus. Lab Setting experience critical.
- Experience with Controlled guidelines.
Source : Cogent Infotech Corporation
