Bioassay Team Lead

Bioassay Team Lead
Our client, a global biologics organisationare currently recruiting for aBioassay Team Leadto join their team on a permanent basis. Technical experience in the following is required; Initiation and Maintenance of Mammalian Cell Lines, Cell Culture Based Bioactivity Testing, ELISA Testing, qPCR Testing. The successful candidate will also have people management/supervisory experience. Experience working in the Biologics industry is essential.

Responsibilities

• Key member of the QC Team, support execution of the strategy and business planning processes, ensuring cross-functional collaboration
• From a QC functional capacity, support the design, construction, and commissioning of the new facility for the production of drug substance
• Support the development of a Biologics QC Bioassay and Biochemistry team including planning, recruiting/hiring, coaching/mentoring, and training
• Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs and safety regulations
• Communicate, collaborate, and cooperate with QC functional teams and other departments to support Lab start-up and routine operations
• Serve as technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviation, and CAPAs
• Support Risk Assessments for projects and business innovations initiatives from a bioassay/biochemistry perspective
• Aligned with the project timelines managing and leading a team will also be required as part of the role
• Prepare, review, and approve technical documents including method protocol, qualification and validation protocols and reports, etc
• Ensure that all Bioassay and Biochemistry testing is completed, reviewed, and approved within agreed turnaround times
• Ensure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards
• Initiate and drive change controls to completion to implement process improvements/improve operation excellence
• Actively participates in lean initiatives such as Kaizen, 5S

• University degree in related science/quality discipline required
• More than 8 years’ experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field
• Previous experience managing and leading a small team would be advantageous
• Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required
• Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required
• Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable
• Previous experience working in a CMO is an advantage
• Demonstratedknowledge and testing experience in an FDA/HPRA approved QC laboratory
• Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals