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QC Microbiology Lead

Employer
RoslinCT
Location
Hopkinton, Massachusetts, US
Salary
Competitive
Closing date
Oct 8, 2023

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Genetics, Biology
Salary Type
Salary
Employment Type
Full time
QC Microbiology Lead (Sun - Wed Shift)

Full Time

Hopkinton, MA, US (On Site)

WHO WE ARE

We at RoslinCT are a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success and at RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Quality Control Microbiology Lead will be responsible for scheduling and collection of environmental monitoring samples, sample management activities, and testing of cell therapy in-process, release and stability product samples. He/she will be responsible for reporting data and writing/revising standard operating procedures (SOPs). He/she may support equipment onboarding and qualification as well as test method qualification in compliance with all applicable quality systems and current cGMPs. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations. This position will be responsible for scheduling and assigning daily tasks.

HOW YOU WILL MAKE AN IMPACT
  • Conduct routine and non-routine analyses of samples for in-process, final product, stability and environmental monitoring.
  • Execute sampling and QC Sample Management activities per procedure or written protocols.
  • Perform environmental monitoring of cleanrooms and controlled areas.
  • Perform sterility and endotoxin testing.
  • Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.
  • Write/revise QC specific procedures and protocols for Cell Therapy manufacturing facility.
  • Support implementation of information technologies that support documentation and data management systems.
  • Participate in investigations, change controls and CAPAs.
  • Leads daily work within QC including scheduling of daily tasks.
  • Work collaboratively with cross functional departments including but not limited to Supply chain, Manufacturing, and Quality Assurance.
  • May interact with external partners on technical matters in relation to microbiological methods.


Minimum Qualifications
  • Bachelor's degree in scientific discipline preferred.
  • 4+ years of industry experience in cGMP QC laboratory
  • Ability to adhere to timelines for testing and reporting of data
  • Knowledge of cGMP/ICH/FDA regulation
  • Ability to function in a team-oriented environment
  • Experience with environmental monitoring and clean room requirements
  • Experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain, mycoplasma)
  • Excellent/Effective written and verbal communications skills
  • Developed troubleshooting and problem-solving skills
  • Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail
  • Ability to work in a fast-paced, collaborative environment, working with minimal direction (once training has been completed) and able to manage workload based on changing priorities
  • Support implementation of information technologies that support documentation and data management systems.
  • Responsible for QC investigations, change controls and CAPAs.

*Flexible shift work may be required on occasion in support of 24/7 manufacturing operations.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.
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