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:

• 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

What We’ll Expect From You: 

• Bachelor’s Degree in Chemistry/Biochemistry/Biology/related field; or Scientific Associate Degree with additional years of relevant experience
• 1+ years of QC analytical experience working within the medical device or pharmaceuticals regulated product environment preferred
• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry preferred
• Hands-on experience and demonstrated organizational skills in a regulated analytical environment preferred
• 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
• Working knowledge of standard laboratory practices and safety

Working hour Requirements:

• Normal business hours with occasional demand of weekend work to support business needs

Physical Demands:

• 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

Travel Requirements:

• <5%

Why You’ll Like Working For Us:

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 https://www.quanterix.com.