- Drive new product introductions (NPI) to manufacturing through assessment of raw materials, drafting of work instructions, and manufacture of pilot scale assay reagents
- Independently carry out development and scale-up activities for both upstream and downstream reagent preparation operations
- Ability to identify and proactively troubleshoot problematic chemistry and scale-up concerns
- Recommend and implement new product development processes and continuous improvement initiatives
- Drive root cause analysis for investigations and resolution of product/process issues
- Perform immunoassay testing on automated and semi-automated instrument platforms
- Participate in authoring/editing new or approved GMP documentation such as SOPs, test methods, work instructions etc.
- Actively support continuous process improvement to increase compliance and maintain a consistent state of laboratory controls
- Bachelor's Degree in a scientific discipline
- Familiarity with application of FDA and/or ISO quality standards in a government regulated industry
- Basic knowledge of standard laboratory practices and safety
- Hands-on experience and demonstrated organizational skills in a regulated analytical environment
- Experience with creating and revising process documentation
- Demonstrated ability to work well within cross-functional teams as a team player
- Possess an ability to learn and master complicated concepts quickly and comfortably
- Ability to generate high quality data under tight deadlines with a collaborative and proactive attitude
- Strong attention to detail
- Strong computer and database skills
- ELISA's and other plate-based methods for routine and non-routine use experience preferred
- Exposure to creation of QC documents and quality events
- Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, bend, kneel, hear, and talk.
- Close Vision
- Lift up to 25lbs
- Operate computer/office machines
- Ability to wear personal protection equipment
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Associate Process Engineer - Billerica, United States - Quanterix
Description
Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company's ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease. Quanterix' technology is designed to enable much earlier disease detection, better prognosis and precise treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease.
ROLE SUMMARY:
We are looking for an experienced and highly motivated Associate Process Engineer to join our Product Transfer team. This position will be responsible for a variety of activities including production of small scale reagents, continuous improvement of existing processes, and establishing manufacturing procedures/work instructions in support of new product in accordance with cGMP.
WHAT YOU'LL DO:
Our Technology: Quanterix' technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit
Our Commitment to Employees: At Quanterix, we take pride in our employees' incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible to be awarded Equity, and we have an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day
DIVERSE & INCLUSIVE WORKPLACE: Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.
Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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