Job DescriptionAbout usThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit .
Position Summary:Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by the TGA, FDA, EMA and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented and maintained. Our team is responsible for ensuring the completion of qualification/validation protocols, batch release and stability testing. We are a quickly expanding site with ever growing opportunities. We believe our workforce are our greatest asset, and are passionate about nurturing and developing future talent!
Key Responsibilities:- Involved in day to day lab running of the Quality Control Chemistry team, including planning of activities and resources, execution of analysis (including but not limited to: cIEF, CE-SDS, UPLC, and HPLC), Peer review and technical review of analyses for completeness and cGMP compliance.
- Take leading role within QC Chemistry team in practical application of the Quality System related to the Quality Control Department, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management,.
- Partake in QC Chemistry equipment maintenance, calibration, equipment/system upgrades and qualification by working with PSG Brisbane Australia’s Engineering and Validation teams closely.
- Supports client focused outcomes for the analysis of stability study samples, method analytical transfer, and qualification and validation studies to agreed timelines.
- Assisting with the revenue milestones of the Company through analytical chemistry outcomes and the release of drug substance (DS) results.
- Ensure the effectiveness of the Quality Control Chemistry Laboratory aligns with EH&S guidelines and Quality Standards.
- Leading, coaching and motivating members of the team.
- Transferring new analytical techniques and assays into the Chemistry Laboratory.
- Assist with regulatory and client audits, representing all aspects of the QC Chemistry Team.
- Ensures the scientific integrity of the QC Teams is maintained, working closely with the data integrity officer.
- Assist with site PPI projects.
- Perform any other legitimate duties as directed by the Manager, QC Operations.
Stakeholder Engagement:Internal: All Internal Departments including QC, QA, and OperationsExternal: Customers, Regulatory Agencies, Other Thermo Fisher Scientific Business both within and external to the PSG, Equipment/Contract Laboratory/Maintenance vendors and contractors
Skills and Experience:Qualifications & Experience- Bachelor of Science (Biotechnology, Chemistry, or closely related degree).
- Post Graduate qualifications – beneficial.
- At least 3 years’ experience in the pharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields, especially in chromatography analysis.
- Knowledgeable in cGMP practices.
- Knowledgeable with various Chemistry laboratory analyses, efficient sample workflows, in process controls and analytical testing, and area/equipment within the Quality Control Chemistry Laboratories.
- Strong background in analytical theory and technical competency with laboratory analysis.
- Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives.
- Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.)
- Ability to work on multiple projects simultaneously.
- Strong team-working and collaborative skills.
- Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint).
- Previous experience with Laboratory Information Management Systems (LIMS), Empower, 32Karat, Smartsheets– desirable.
Skills & Attributes:- Adaptability: Ability to adapt to daily business requirements.
- Collaborating: You will have the ability and competency to work with all departments and colleagues of varied backgrounds.
- Continuous Improvement: Drive PPI
- Quality Orientation: Ability to interpret and apply cGMP principles, strong attention to detail, and accurate completion of test records. Strives for right first time in every task undertaken.
Other Job Requirements:- Deliver the best technical and scientific solutions to improve product value. Build a culture of engagement, accountability and a shared commitment to excellence.
- Abide by all EH&S policies and procedures, operate our business in a safe, focused, responsible, and ethical fashion. Work safely and only perform tasks if currently competent and/or authorised, participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.
We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. If you are a motivated individual with a passion for demand planning and inventory management, we invite you to apply for this exciting opportunity. Watch as our colleagues explain .Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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