Engineer I, Biochemical Manufacturing

MESO SCALE DIAGNOSTICS, LLC.•Rockville, MD

9d•$67,900 - $101,000

About The Position

This position applies principles of biochemistry to design, develop, and validate biological processes and to improve and standardize biochemical manufacturing processes using FPLC and HPLC instruments. The role supports manufacturing process improvements, equipment and software configuration, standard operating procedures, validation, technical transfers, troubleshooting, and training. It also performs protein purification by FPLC and HPLC size-exclusion chromatography analysis of customer samples. Duties may vary depending on departmental requirements. The position is based in a standard industrial laboratory environment. Up to 80% of the workday may be spent at a lab bench and/or in the cleanroom. The role requires occasional lifting of up to 25 pounds and the ability to communicate, exchange information, and use equipment necessary to perform the job. The annual base salary range is $67,900 to $101,000. Employees may also qualify for a discretionary or non-discretionary bonus. MSD offers medical, dental, vision, and prescription coverage; a 401(k) plan with company matching; flexible spending accounts; company-paid short- and long-term disability and group life and accidental death and dismemberment insurance; paid vacation, sick leave, and holidays; paid parental leave; and an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

Requirements

Bachelor’s degree in Engineering, Biotechnology, Chemistry, Biology, or a related field.
One year of hands-on experience with FPLC or HPLC.
Working knowledge of FPLC or HPLC.
Thorough knowledge of scientific fundamentals and an analytical background.
Mechanical aptitude, including the ability to troubleshoot equipment.
Ability to learn and adhere to standard laboratory techniques and safety precautions.
Ability to research scientific concepts and system and software capabilities, and apply the information.
Excellent oral and written communication and interpersonal skills.
Ability to communicate issues, problems, and results that affect timelines, accuracy, and reliability of laboratory data.
Proficiency in the MS Office Suite.
Ability to multitask and work productively in a demanding manufacturing environment with changing priorities.
Ability to learn additional software applications and tools as required.
Ability to work independently and as an effective team member.

Nice To Haves

Working knowledge of Äkta systems.
Knowledge of cGMP and/or ISO certification.

Responsibilities

Design and test ways to apply biochemical principles to manufacturing process improvements that improve product quality and/or quantity.
Design equipment and software configurations suited to the product range and process technologies.
Assist with implementing updated standard operating procedures.
Collaborate on equipment and software validation documents and coordinate validation efforts.
Collaborate on draft technical-transfer documents for new processes using FPLC, HPLC, and/or other specialized instruments operated by the Biochemical Manufacturing team.
Troubleshoot equipment, including FPLC and HPLC, and document troubleshooting steps and preventative measures to streamline production processes.
Collaborate with other specialists to support the efficient operation of production facilities.
Assist with technical training for manufacturing team members on new and updated processes.
Ensure potential safety issues related to the environment and equipment are considered at all stages.
Maintain preventative maintenance schedules for specialized laboratory equipment.
Purify protein solutions via FPLC to prepare conjugation or coating solutions.
Use HPLC to perform size-exclusion chromatography analysis on customer samples and report percentages of monomer, aggregation, and free-tag.