Early Phase QC Associate Scientist (Biology)

Job Description

The Opportunity

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Reporting to the Manager of Analytical testing, this position will perform the testing and review of laboratory data supporting the validation and transfer of methods, and the release and stability monitoring of clinical trial material. This Early Phase QC Associate Scientist position will focus on methods/techniques including but not limited to qPCR, cell culture, Flow Cytometry and etc. The associate scientist will be responsible for ensuring that samples are tested according to Seqirus quality requirements, and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements.

This position will be based in Holly Springs, North Carolina. The position requires the ability to build and maintain strong relationships and collaborate effectively with colleagues within Quality Control, QA, and BPD.

The Role

Ensure adherence to phase appropriate clinical Quality Control processes and procedures

• Executes all tasks in accordance with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements as written

Execution of Quality Control Activities in support of Clinical Programs

• Performs release and stability testing on pre-clinical and Clinical Trial Material
• Performs method validation and transfer experiments/lab work as needed
• Performs peer review of data
• Performs testing and associated tasks per applicable SOPs and protocols
• Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
• Participates in cross-training to support staff availability within QC department
• Develops expertise in assigned assays/techniques
• Initiates and authors deviation and invalid assay assessments
• Assists with Change Controls and CAPAs

Continuously improve quality control processes to reduce cost and improve quality

• Identify and report opportunities for improvement in quality control processes and procedures

Your skills and experience

• Bachelor degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.)
• 1-2+ years' lab experience
• Experience with Cell Culture and/or PCR, and/or Flow Cytometry
• Experience with GMPs, safety regulations, and data integrity.
• Experience with analytical methods and related instrumentation.
• LabWare LIMS experience is preferred.

Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

About Us


Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!