About this role
Job title: Engineer I, Biochemical Manufacturing
POSITION SUMMARY: This position is responsible for using principles of biochemistry to design, develop, and validate a diverse range of biological processes. Responsible for improving and standardizing biochemical manufacturing processes utilizing FPLC and HPLC instruments within the Manufacturing department.
DUTIES AND RESPONSIBILITIES
- Design and test new ways to leverage biochemical principals for manufacturing process improvement initiatives that deliver better quality and/or quantity of products.
- Design equipment and software configuration to suit the product range and the process technologies.
- Assist with the implementation of updated standard operating procedures.
- Collaborate on equipment and software validation documents, and coordinate validation efforts.
- Collaborate on draft documents for technical transfer of new processes utilizing FPLC, HPLC, and/or other specialized instruments operated by the Biochemical Manufacturing team.
- Troubleshoot equipment including but not limited to FPLC and HPLC;
- Document troubleshooting steps and preventative measures to better streamline production processes.
- Collaborate with other specialists to ensure the efficient running of production facilities.
- Assist with technical training of manufacturing team members for new and updated processes.
- Ensure that potential safety issues related to environment and equipment are considered at all stages.
- Maintain preventative maintenance schedules for specialized lab equipment.
- Purify protein solutions via FPLC to prepare conjugation or coating solutions.
- Utilize HPLC to perform size exclusion chromatography analysis on customer samples in order to report percentages of monomer, aggregation, and free-tag.
- Specific duties may vary depending upon departmental requirements.
EXPERIENCE AND QUALIFICATIONS
- Bachelor’s degree in Engineering, Biotechnology, Chemistry, Biology or related field.
- One year of hands-on experience with FPLC or HPLC is required.
KNOWLEDGE, SKILLS AND ABILITIES
- Working knowledge of FPLC or HPLC required.
- Working knowledge of Äkta systems highly preferred.
- Thorough knowledge of scientific fundamentals and analytical background.
- Demonstrated mechanical aptitude that includes ability to troubleshoot equipment
- Demonstrated aptitude for learning and adhering to standard laboratory techniques and safety precautions.
- Ability to research scientific concepts, system and software capabilities and apply information.
- Knowledge of cGMP and/or ISO certification highly preferred.