Bioassay Specialist
This Bioassay Senior role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of a new strategic facility. This tremendous opportunity will be responsible for qualifying the Bioassay analytical lab and the transfer of Bioassay analytical methods. Additional development opportunities within the micro and chemistry lab will be strongly considered to recognize the tremendous value of knowledge / experience gained by the candidate during the project phases.
To maximize the development opportunity, the candidate will be the key leading talent in analytical Bioassay techniques and developing the flow of testing through the lab, to ensure the lab will be best in class across our industry, a benchmark for others to aspire to. The candidate will support the complete analytical lab build.
The facility will utilize the latest innovations in technology and automation and latest in analytical techniques. Together, the team will build the future of biologics through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team. The full analytical scope will incorporate micro, chemistry, bioassay, raw materials, stability and in-process). Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc) will allow the candidate challenge current thinking in designing for the future. The candidate will have responsibilities in analytical transfer and qualification of methods.
Key Responsibilities
- Perform activities for general lab readiness, laboratory equipment qualification and method transfers.
- Strong knowledge and experience of Bioassay methods.
- Perform and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements.
- Follow up-to-date analytical practices with reference specifications, regulations and industry standards.
- Plan and maintain the laboratory testing schedule to achieve an efficient QC system.
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
- Ensure training is current for all job functions performed.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Delivery of area performance to meet or exceed performance or quality goals.
- Promote and participate the implementation and maintenance of the relevant safety programmes.
- Participate and Comply with Quality Management System requirements.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools.
- Assist in the "operationalising" of the lab with a strong focus on MPS.
- Train and help develop other analyst within the lab.
- The candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role.
Qualifications
- Degree qualification (Science/Quality/Technical). Master preferred.
- Desirable evidence of Continuous Professional Development.
- Preference Lean Six Sigma
Key Experience
- 3-5 years industry experience with significant knowledge and experience in working in a Bioassay lab unit and working with contract labs
- Experience in Potency Elisa method
- Working knowledge of QC Systems (EN, LIMS) and Trackwise
Interested?
- Call Jack on 01-6455250 for more information or click apply below!
