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June

Quality Control Team Leader Bio-chemistry

Thermo Fisher Scientific - Brisbane Grove, NSW

Biotech, R&D, Science
Source: uWorkin

JOB DESCRIPTION

Thermo Fisher Scientific’s Mission is to enable our customers to make the world healthier, cleaner and safer, and the global coronavirus (COVID-19) outbreak is a powerful reminder of the importance of that Mission. In fact, Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak. Our efforts have been particularly focused in supporting analysis of the virus, diagnosis, personal protection, and ultimately helping in the development of new therapeutics and vaccines.

Job Title

Quality Control Team Lead, Bio Chemistry

Reports to: Senior Manager Quality Control

Position

Location: Brisbane, Australia

Direct Reports: 7

How You'll Make An Impact

The network of Patheon’s drug substance manufacturing sites includes St. Louis, USA, Groningen, Netherlands and Brisbane, Australia. The performance of each manufacturing site is linked closely to the timely introduction of new projects, right first-time manufacturing, and the on time delivery of products to customers.

As the Quality Control Team Lead for Bio Chemistry, you will ensure timely and scientifically sound output in accordance with international regulatory requirements, related to assay development, assay qualification/validation, in-process production samples, final formulated products and systems with international quality requirements and in line with the customer specific requirements.

You will be responsible for day to day management of the Quality Control Bio-Chemistry Laboratory team, including planning of activities and resources, execution of analysis, reporting of results, and reporting of key performance indicators.

What will you do?

  • Undertake (but not limited to): Electrophoreses (i.e. SDS-Page), Impurity and Activity assays via Plate Readers (i.e. Binding ELISA, Residual HCP, Residual Protein A, Endotoxin, etc.), UV-VIS (i.e. OD280, A280), SoloVPE, and impurity via qPCR DNA.
  • Establish team goals and objectives, ensuring high quality analytical stability study, analytical transfer, qualification and validation reports to agreed timeline.
  • Undertake equipment maintenance and calibration.
  • Assist project and validation team with equipment/system upgrades and improvements.
  • Consult with the business regarding Bio-Chemistry analysis methodology and release results.
  • Peer review and technical check of analysis for completeness and correctness.
  • Ensure effectiveness of the Quality Control Bio-Chemistry Laboratory in order to safe guard the output, whilst operating within EH&S guidelines and Quality Standards.
  • Contribute to the effective delivery of high value analytical services to clients.
  • Track and report milestones, ensuring efficiencies are gained through continual improvement.
  • Lead, coach, motive and mentor your team.
  • Lead team performance through KPI and goal settings.
  • Managing the introduction of new analytical techniques and assays into Bio-Chemistry.
  • Monitor new relevant technologies which may offer increased cost effective and robust solutions to the business.
  • Assist with regulatory and client audits, representing all aspects of QC.
  • Ensure the scientific integrity of the QC teams is maintained, working closely with the data integrity officer.
  • Facilitate atypical, out of specification or out of trend investigations with the team to ensure swift resolution, recommending appropriate resolution.
  • Understanding of the Quality Control practices and principles across the full spectrum of site manufacturing services.
  • Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and ability to directly develop, participate, and advise others on the appropriate and efficient application of these processes.
  • Practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.
  • Lead and assist with PPI projects
How will you get here?

Education, Skills And Experience
  • Hold a Bachelor of Science (Bio-Technology, Chemistry, or closely related degree). A Post Graduate qualification would be highly regarded
  • Demonstrated no less than 5 years Quality Control experience within the pharmaceutical industry
  • Solid team leadership experience
  • Expertise with test method development, qualification, validation.
  • Strong working knowledge of cGMP practices within the pharmaceutical industry
  • Knowledgeable with various Bio-Chemistry and Chemistry laboratory analysis, efficient sample flows, raw material testing, in process controls and drug substance testing, and area/equipment within the Quality Control Bio-Chemistry, Chemistry, and Environmental Laboratories.
  • Strong background in analytical theory and technical competency with laboratory analysis.
  • Experience with regulatory inspection practices through direct agency engagements.
  • Expertise with principles of Aseptic Techniques
What will put you ahead of the competition?
  • 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).
  • Good knowledge of Laboratory Information Management Systems (LIMS) – desirable.
  • Good knowledge of Smartsheets – desirable.
What’s in it for you?
  • A competitive salary and performance related bonus structure
  • Access to Thermo Fisher’s global University
  • Development opportunities as part of a rapidly growing global organisation