Who We AreCell Therapies Pty Ltd (CTPL) is an incorporated Australian Proprietary Company which manufactures and deploys advanced cell-based therapies to the global cell and gene therapy (CGT) market.The evolution of Cell Therapies Pty Ltd will continue through its commitment to supporting local and international research and development activities in addition to a pipeline of new commercial contracts supplying Australian and International patients.About the RoleReporting to the Analytical Services & Technology Manager, the Senior QC Analyst – Translation will be responsible for assay development and validation for development or Tech Transfer project activities as applicable. The Senior QC Analyst – Translation shall perform additional testing as required to ensure project delivery timelines are adhered to.This full-time position is located at our new state of the art Melbourne facility located at the Peter MacCallum Cancer Centre on the edge of the CBD in Australia's most dynamic biomedical precinct.DutiesGenerate protocols, reports and SOP's for developed or transferred assays;Execute testing protocols related to QC test method development or qualification/validation;Project team representative for projects pre-routine manufacturing;Ensure the quality and quantity of additional resources for sample execution as required to meet project deliverables;Identify and implement improvements to QC processes and workflows;Ensure proper maintenance and calibration of QC equipment, support laboratory activities, and uphold cGMP compliance;Provide guidance and training to junior staff in QC test methods and protocols;Monitor and maintain adherence to cGMP and regulatory requirements;Demonstrate flexibility and critical thinking in resolving technical issues and ensuring high-quality outputs.Skills & ExperienceEssentialBachelor's degree in life sciences (BAppSc or BSc) or equivalent industry experience;Previous experience working within a CDMO environment and associated client interactions;Minimum 5 years' experience in a Laboratory (Research, Pathology or GMP);Experience/High technical competency in one of the following areas: flow cytometry, qPCR, cell culture, cell based assay including ELISA;Demonstrable ability to work and communicate cooperatively in a multidisciplinary team;A diligent and quality-driven approach;Ability to multitask and work autonomously as well as in teams;Willingness to work shifts and weekends as necessary.DesirableExpert knowledge of method development and validation of QC assays as applied to clinical and commercial phase products;Highly proficient in QC testing platforms related to cell therapy products e.g. flow cytometry, PCR, ELISA and safety tests;Proficiency in cGMP standards and manufacturing under aseptic conditions;Demonstrated communication and negotiating skills;Demonstrated decision making ability;This is a great opportunity for a driven, collaborative and curious professional to join an organisation with purpose, passion for excellence and the aspiration to be a global leader in cell and gene therapy.At CTPL we are passionate about the work we do but equally passionate about our people. We want everyone to bring their true self to work. We support the wellbeing of our staff through mindfulness sessions, continuous improvement activities and 5 wellness days a year.The Salary offered will be commensurate with skills, experience and industry standards. Company specific GMP training will be provided as part of the induction process.In applying, please provide a cover letter that addresses the key selection criteria.Right to live and workYou must have the right to live and work in this location to apply for this job.Job Types: Full-time, PermanentPay: $90,000.00 – $105,000.00 per yearBenefits:Professional development assistanceReferral programSchedule:Monday to FridaySupplementary Pay:Penalty ratesApplication Question(s):How many years' experience do you have as a Quality Control Analyst?Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?Have you completed a qualification in science?What's your expected annual base salary?How much notice are you required to give your current employer?Work Authorisation:Australia (Required)Work Location: In person
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