Responsible for developing, characterizing and validating manufacturing processes to produce biochemical assay plates and related consumables.
DUTIES AND RESPONSIBILITIES:
• Review existing manufacturing processes to determine if changes are needed to improve quality and quantity of products, reduce any variations between lots produced and expand product portfolio.
• Make recommendations to manager to improve/enhance processes as needed.
• Design and conduct process experiments on manufacturing and pilot scale equipment to determine if/how changes affect product(s) properties.
• Work with suppliers to improve product quality and lot-to-lot reproducibility of purchased raw materials.
• Collaborate with other departments to determine if improvements are needed to enhance product performance.
• Support the corporate validation effort as required for ISO certification and FDA approval.
• In accordance with standard operating procedures, provide documentation of all experimental results and present findings to supervisor and other appropriate staff.
• May provide training and/or supervision for co-workers.
• Specific duties may vary depending upon departmental requirements.
EXPERIENCE AND QUALIFICATIONS:
• Bachelor’s degree in chemical/biochemical engineering or related field.
• Minimum of three years of relevant experience.
o An advanced degree may be substituted for years of relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES:
• Strong knowledge of process development techniques (such as process optimization, process control, design of experiments) and statistical analysis.
• Superior analytical and problem solving skills.
• Advanced knowledge of quality standards such as GMP, ISO 9001 and ISO 13485 required.
• Ability to work in a technically challenging, team-oriented environment.
• Demonstrated ability to move project tasks forward in an orderly and structured fashion.
• Excellent oral, written communication and interpersonal skills.
• Proficiency with the MS Office Suite and Minitab.
• Demonstrated knowledge of coating techniques, fluid dispensing, drying/desiccation techniques and protein stabilization.
• Demonstrated 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 manufacturing and laboratory equipment, and move about the office and manufacturing floor.
WORK ENVIRONMENT:
This position will spend time in a Clean Room environment, with some travel between local office sites.
COMPENSATION SUMMARY:
The annual base salary for this position ranges from $88,100 to $134,375. 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.
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.
