Engineer I, Biochemical Manufacturing

MESO SCALE DIAGNOSTICS, LLC.; Rockville (MD); On-site; USD 68,000 - 101,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company matching

Paid vacation and holidays

Disability and life insurance

Parental leave

Job summary

MESO Scale Diagnostics, LLC. seeks a Biochemical Manufacturing Specialist to design, develop, and validate processes using FPLC and HPLC. You will improve manufacturing workflows, configure equipment, and contribute to SOPs and tech transfers within the Manufacturing department.

The role requires hands-on FPLC/HPLC experience, strong analytical skills, and the ability to collaborate across teams in a fast-paced lab environment.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Chemistry, Biology or related field.
• One year of hands-on experience with FPLC or HPLC is required.

Responsibilities

• Design and test manufacturing process improvements using biochemical principles.
• Design equipment and software configuration to suit product range and process technologies.
• Assist with updated standard operating procedures (SOPs).
• Collaborate on equipment and software validation documents and validation efforts.
• Draft technical transfer documents for new processes using FPLC/HPLC.
• Troubleshoot FPLC/HPLC equipment and report issues.
• Document troubleshooting steps to streamline production.
• Collaborate with specialists to ensure efficient operation of production facilities.
• Assist with technical training for manufacturing staff on new processes.
• Consider safety issues related to environment and equipment at all stages.
• Maintain preventative maintenance schedules for lab equipment.
• Purify protein solutions via FPLC for conjugation or coating solutions.
• Use HPLC size exclusion to report monomer/aggregation/free-tag percentages.

Skills

FPLC

HPLC

Äkta systems

cGMP knowledge

ISO knowledge

MS Office Suite

Troubleshooting

Communication

Teamwork

Education

Bachelor’s degree in Engineering, Biotechnology, Chemistry, Biology or related field

Tools

Äkta systems

Job description

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.
• 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.

Physical Demands

• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and occasional lifting up to 25 lbs.
• Up to 80% of the day may be spent at a lab bench and/or in the cleanroom.

Work Environment

Standard industrial laboratory environment.

Compensation Summary

The annual base salary for this position ranges from $67,900 to $101,000. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company’s overall success.

Benefits Summary

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with 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.

Eeo/Aa Statement

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.

Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.