The QC Potency Assay Team Lead will lead a team of cell-based potency assay scientists to provide cGMP-compliant service in QC lab and support the design, planning, and set-up of the Vaccines QC lab. The Lead will also be responsible to provide the highest quality analytical support for vaccines manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.
Develop/build a world-class cell-based potency assay QC team including planning, recruiting/hiring, coaching/mentoring, and training for staffs and group leaders.
Serve as a technical expert to develop, qualify, and validate cell-based potency methods (qPCR and immunoplaque) for vaccines to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements.
Prepare, review, and approve technical documents including method protocols, qualification and validation protocols and reports, etc.
Provide technical guidance/direction to subordinates, as well as evaluate new analytical technologies to enhance department capabilities.
Provide GMP quality oversight supporting non-conformances, atypical/OOS investigations, change controls, and CAPAs.
Lead the group to meet the preset goal/budget of the department through streamlining/optimizing the workflow and maximizing the operation efficient while maintaining full compliance.
Assist in the lab design and planning for the Vaccines QC labs.
Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.
Ability to handle regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance.
Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
Continuously improve QC quality systems/documents, enhance QC data quality, and deliver high quality results
Create a safety culture, enforce safety measures and ensure QC staff working in a safe environment
Ensure QC staff receive appropriate GMP training and maintain compliance and high-quality standards
Ability to work in a team environment and independently as required
Strong and effective people management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas.
Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3
Demonstrates good understanding of analytical and QC operations in the biopharmaceutical/vaccine industry.
Minimum of 8 years of vaccine industry experience preferred, or minimum 10 years relevant pharmaceutical/biopharmaceutical/ in CMC process development and/or GMP manufacturing.
Working knowledge and understanding of current regulations and industry trends for vaccines product development, manufacture and testing, including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance
Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required. Bachelor, Master, or PhD Degree in immunology, virology, life science, analytical or related discipline.
Other skills, attributes & experiences:
Must be a self-starter, self-motivated, and highly flexible in this Ireland based position with ~10% travel.
Must be organized and detailed-oriented.
Proven experience in creating and carrying out successful plans and processes to solve complex problems.
Work closely with team members across all WuXi Biologics units and management team to ensure coordination of all efforts and real-time communication with all stakeholders.
Proficiency in English is required.
Excellent communications skills (verbal, written, and presentation skills).
This is an excellent opportunity to join an established company as it expands its Irish operations. This is a permanent full-time opportunity and comes with excellent salary and full benefits package.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aidan Crowley at 021 4289605 or send your CV to email@example.com