Overview

Specialist, QC Biochemistry – Protein Analysis Job at Seqirus A CSL Company – 3.8 Holly Springs, NC

Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are 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.

Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are 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.

Job Summary

Reporting to the Analytical Science and Technology Sr. Manager in Holly Springs. The role is accountable for Quality Control method validation lifecycle management, method development and method standardization/robustness. The validation specialist is an SME in testing methodology, able to troubleshoot technical issues, develop current and existing methods and be current with the latest analytical testing technologies. The role requires the execution of intra site method transfers and SME input into regulatory filings/audits and investigations. Responsible for experimental design on key projects that involve new technologies and processes to QC. The employee is required to review data generated from validation activities and bring to the attention of Management any detrimental trend or deviation identified.

Major Accountabilities

Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written

Participates preventive action & continuous improvement programs to reduce operating costs

Leads cross-training to support staff availability within QC department

Owns, develops, and maintains methods and GSOPs

Subject matter expert in assigned assays/techniques

Writes applicable protocols and reports

Executes lab studies to support various projects

Leads method transfers, validations and verifications

Owns/authors deviation and invalid assay assessments

Performs peer review of data as required

Plans and schedules routine operations with QC

Attends project related meetings as departmental representation as required

Participation in quality risk assessments

Qualifications

Bachelor’s degree in related scientific field

6+ years of laboratory experience OR 6+ years with advanced degree OR equivalent related to Biochemistry/Chemistry

Subject matter expert in biochemistry/protein analysis/protein chemistry

Knowledge of GMPs, safety regulations and data integrity

Knowledge of method validation and transfer

Ability to communicate technical knowledge

Watch our ‘On the Front Line’ video to learn more about Seqirus

About the Company

Company: Seqirus A CSL Company – 3.8

Company Location:  Holly Springs, NC

Estimated Salary:

About Seqirus A CSL Company - 3.8