Engineer IV, Manufacturing Research

Reposted 22 Days Ago
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Gaithersburg, MD, USA
In-Office
117K-178K Annually
Expert/Leader
Biotech
The Role
The role involves leading research in high-volume manufacturing methods for diagnostic consumables, designing scalable systems, and ensuring compliance with quality standards while collaborating across teams.
Summary Generated by Built In

POSITION SUMMARY

This position will play a critical role in supporting high-impact research initiatives at MSD related to the research and development of manufacturing methods for clinical consumables. This position will work with a team of engineers and scientists to design and evaluate novel and high throughput manufacturing techniques for next generation diagnostic consumables, and eventually work closely with an internal automation team to scale up to high volume production. The role involves close collaboration with both internal departments and external partners to drive innovation and achieve research objectives. 

DUTIES AND RESPONSIBILITIES

  • Lead a multidisciplinary team in the research and development of new high-volume manufacturing methods for consumables. 
  • Guide the consumable design process to be highly scalable and high quality. 
  • Develop and prototype systems for consumable manufacturing and inspection.
  • Make and guide key technical decisions throughout research and development activities.
  • Perform hands-on work as part of active experimental programs.
  • Prepare and present project designs and technical reports as needed.
  • Create and/or update manufacturing and project documents and procedures. 
  • Work with Quality to ensure products are manufactured and/or assembled according to quality guidelines.
  • Ensure compliance with relevant regulatory standards.

EXPERIENCE AND QUALIFICATIONS

  • Bachelor’s degree in Biology, Chemistry, Biotechnology, Engineering or related field is required.
    • Master’s degree in a similar field is preferred.
  • Minimum 10 years of experience in high throughput plastic manufacturing
  • Minimum 5 years of experience manufacturing biological products preferred
  • Experience with cGMP and/or ISO certification is preferred
  • Desirable skill sets may include but not be limited to the following:
    • Manufacturing immunoassays and/or reagents.
    • In-vitro diagnostic devices and consumables.

KNOWLEDGE, SKILLS AND ABILITIES

  • Deep experience with several of the following manufacturing methods at scale:
    • Roll-to-Roll processing and converting
    • Sheet-to-sheet or sheets-on-shuttle processing
    • Plastic film and metal foil processing techniques:
      • Bonding (thermal, ultrasonic, laser, adhesive, solvent) 
      • Forming (stamping, thermal embossing, drawing, ultrasonic) 
      • Cutting (laser, knife)
    • o Liquid integration (Blister packs design and formation or similar)
      • Plastic vapor barriers (materials and methods)
      • Liquid addition and sealing
      • Lyophilized reagent addition and sealing
    • Coating techniques such as:
      • Liquid and ink: Slot Die, micro gravure, Meyer rod, ink jet, spray coating, screen printing, and dip coating
      • Vacuum based: sputtering and evaporation
    • Biological handing and coating
  • Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
  • Ability to lead and guide staff to meet department goals.
  • Demonstrated critical thinking and analytical skills, as well as the ability to handle complex situations and demonstrate sound judgment and problem solving.
  • Excellent oral, written communication and interpersonal skills. 
  • A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding research environment with changing priorities.

PHYSICAL DEMANDS

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT

This position will operate in the following areas of the organization:

  • Traditional office environment;
  • Chemistry and BSL-1/BSL-2 lab environment;
  • Engineering prototype and production space

COMPENSATION SUMMARY

The annual base salary for this position ranges from $116,600 to $177,800 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 STATEMENT

MSD is an Equal Opportunity 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, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Skills Required

  • Bachelor's degree in Biology, Chemistry, Biotechnology, Engineering or related field
  • Minimum 10 years of experience in high throughput plastic manufacturing
  • Minimum 5 years of experience manufacturing biological products
  • Experience with cGMP and/or ISO certification
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The Company
HQ: Rockville, MD
707 Employees
Year Founded: 1995

What We Do

Founded in 1995, Meso Scale Discovery (MSD) is a global leader in the development, manufacture, and commercialization of innovative assays and instruments for the measurement of molecules in biological samples. MSD’s proprietary MULTI ARRAY technology enhances medical research and drug development by enabling researchers to profile many biomarkers simultaneously in a single sample without compromising assay performance. MSD’s technology has been widely adopted by researchers in pharmaceutical companies, government institutions, universities, and clinical laboratories worldwide for its high sensitivity, excellent reproducibility, and wide dynamic range. Throughout its history, MSD has continued to evolve its technology platform to enable researchers to solve complex biological questions and, as the Company looks toward the future, it is expanding into clinical applications and the emerging fields of personalized medicine and companion diagnostics.

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