Engineer I, Biochemical Manufacturing

MSD Careers•Rockville, MD

59d•Onsite

About The Position

This position is responsible for using principles of biochemistry to design, develop, and validate a diverse range of biological processes. The role focuses on improving and standardizing biochemical manufacturing processes utilizing FPLC and HPLC instruments within the Manufacturing department.

Requirements

Bachelor’s degree in Engineering, Biotechnology, Chemistry, Biology or related field.
One year of hands-on experience with FPLC or HPLC is required.
Working knowledge of FPLC or HPLC required.
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.
Excellent oral, written communication and interpersonal skills.
Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
Proficiency in MS Office Suite.
Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities.
Ability to learn additional software applications/tools, as required.
Ability to work both independently and as an effective team member.

Nice To Haves

Working knowledge of Äkta systems highly preferred.
Thorough knowledge of scientific fundamentals and analytical background.
Knowledge of cGMP and/or ISO certification highly preferred.

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.