QC BioAnalytical Sciences

QC BioAnalytical SciencesPurposeThis job specification outlines the general responsibilities associated with the role of QC BioAnalytical Sciences - Senior Associate. This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues.Responsibilities:Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.Participate in the peer review of analytical data.Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.Lead training of staff on technical aspects of job as required.Develop, revise and implement procedures that comply with appropriate regulatory requirements.Qualification of analytical equipment and related testing functions.Participate in Analytical Method TransfersCompliance with Standard Operating Procedures and Registered specifications.Ensure the laboratory is operated in a safe mannerMaintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.Participate in the generation and update of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.Participate in regulatory agency inspections as required.Plan and implement procedures and systems to maximise operating efficiency.Manage and contribute to the achievements of department productivity and quality goals.Qualifications Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquid-handling robots is also preferable.A Bachelor's degree (BSc) in a relevant science discipline (Life Sciences, Biochemistry, Cell Biology, Biotechnology) Significant hands-on laboratory experience in a regulated biotech/pharma QC environment (cell-based assays, immunoassays, cell culture) is expected.Experience in a GMP lab is highly desirable and often required for senior associate/lead type roles.Hands-on experience with cell-based potency bioassays (i.e., functional assays using live cells)Strong experience with cell culture (e.g., maintaining, treating, using cells in assays)Experience with ELISA is required. Ability to lead/coordinate lab operations, with minimal supervision — e.g., plan and execute multiple complex assays, non-routine methodsAbility to provide technical guidance, act as role model for colleaguesGood working knowledge of lab quality systems: SOPs, equipment qualification, method transfer, deviations/investigations, regulatory compliance (cGMP/cGLP)Strong analytical, troubleshooting skills; ability to review peer data; lead method transfers/validationsTraining & mentoring of staff as required, and continuous improvement mindset