Key Responsibilities
Perform a wide variety of analytical techniques including cell‑based bioassays, immunoassays, cell culture (use of cells to execute bioassays), and aseptic technique. Experience with liquid‑handling robots is also preferable.
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 resolve technical issues.
Lead training of staff on technical aspects of the 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 transfer.
Compliance with standard operating procedures and registered specifications.
Maintain quality systems within the QC laboratories to ensure ongoing compliance with cGLP and cGMP.
Ensure timely completion of laboratory investigation reports and deviations through non‑conformance procedures.
Participate in the generation and update of SOPs, 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
Hold a degree in Science/Biochemistry or related discipline.
Must be confident working with cells to execute bioassays within a GMP environment.
Minimum 2 years’ pharmaceutical industry experience.
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