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QC Scientist Microbial Control at US02 Lonza Biologics Inc.

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Portsmouth, New Hampshire

Job Description:


Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The QC (Quality Control) Scientist, Microbial Control, provides leadership for the QC Microbiology Scientists Group, prioritizing activities and overseeing completion of projects to ensure timeliness and quality. Trains and supervises staff and works cooperatively with site leadership to achieve quality and compliance goals. Ensures that microbiological aspects of tech transfers are executed in a manner that ensures acceptability to regulatory agencies. Guides development of EM and utility monitoring strategies. Oversees EM and utility trending programs, including timely issuance of trending reports. Leads EM investigations and provides technical support for manufacturing investigations for contaminations and bioburden excursions. Works closely with site and Global microbial control teams to drive continuous improvement. Interacts with regulatory agency personnel during inspections; leads development of robust responses to inspection observations concerning EM and microbial control.

Key Responsibilities:

  • Develop and maintain the EM Strategy for the site. Interact with site and Global microbial control teams and other stakeholders to ensure that manufacturing processes are maintained in a state of control

  • Provide guidance to staff in execution of projects

  • Represent QC Microbiology and Lonza in regulatory agency inspections, customer audits and meetings to receive/deliver information, request and requirements.

  • Measures throughput, performance and other appropriate metrics and report them to management

  • Develop the technical, GMP and leadership skills of QC personnel and perform mid-year and annual reviews of supervised QC personnel

  • Additional responsibilities include, but not limited to, leading OE (operational excellence) initiatives, Improvements, hiring of staff

Key Requirements:

  • Bachelor’s degree and/or advanced graduate degree (MS, PhD) required. Preferred area of study: Microbiology, Biochemistry or equivalent Science Field

  • Experience in a GMP environment preferred.

  • Substantial experience in applicable QC assays and instrumentation.

  • Excellent written and verbal communication skills as well as a demonstrated ability to present ideas.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.