JT052 - ASSOCIATE PILOT PLANT at Quality Consulting Group – Cambridge, Massachusetts

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Perform large-scale upstream cell culture and downstream purification manufacturing operations up to the 200L-500L scale spanning from vial thaw through freezing of formulated drug substance.
• Operate, setup, and troubleshoot bioprocessing equipment such as rocking and single-use bioreactors, single-use chromatography and filtration systems (TFF, VF, UFDF), and others as needed.
• Perform testing of samples on various analytical instruments.
• Document work in electronic lab notebooks per GDP principles while following appropriate SOPs.
• Write, review & revise documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc).
• Monitor and analyze process performance for atypical trends and improvement opportunities.
• Perform basic troubleshooting and collaborate with Management, Engineering, Automation and others as appropriate to resolve manufacturing events in a timely manner.
• Escalate appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Adherence to all regulatory requirements, written procedures, policies, and safety guidelines at all times.

Qualifications:

• Bachelor’s degree in Chemical Engineering (strongly preferred), Physics, Bioengineering, rather than just Chemistry, Biology.
• 1–5 years of relevant experience (academic, co-op, internship, or industry).
• Knowledge of basic scientific/physical concepts such as pH, pressure, flowrate, mass, volume, density, geometry; ability to formulate and manipulate basic algebraic equations; ability to calculate basic quantities such as area, volume, density, flowrates, averages, percentages, dilutions).
• Digital Proficiency (ability to use basic computer programs such as Microsoft Word, Excel, PowerPoint, Outlook, Google Chrome, Windows File Explorer).
• Ability to interpret and apply GDP, FAIR, and ALCOA+ principles to everyday work.
• Monday–Friday, approx 8:00 a.m. – 5:00 p.m. on site.
• Manager is flexible with 8:00–9:00 a.m. start, but:
• Weekends & after-hours: Due to cell culture & process schedules, there will be some weekend and evening work.
• Daily stand-up at 9:05 a.m. is mandatory; must be present and engaged
  Initial term: 12 months.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.