ER018 | Senior Manager, Head of Biochemistry and Quality Control

ER018 | Senior Manager, Head of Biochemistry and Quality Control

28 May
Thermo Fisher Scientific

28 May

Thermo Fisher Scientific


Thermo Fisher Scientific in ANZ

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

When your part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.

Job Title: Head of Biochemistry and Quality Control

Reports to: Director of Quality

Position Location: Woolloongabba Brisbane

Number of Direct Reports: 6

Permanent Full-Time opportunity

At the Brisbane Pharma Services Group (PSG) Biologics site, we are a contract manufacturing organization (CMO) specialising in the production of biopharmaceuticals from mammalian cell culture. We supply manufacturing services including limited process development and contract “good manufacturing practice” (cGMP) grade drug substance to customers around the globe. These state-of-the-art medicines help cure cancer, rheumatoid arthritis, wet amacular degeneration and other chronic and acute diseases.

How will you make an impact?

This role is responsible for leading and overseeing all the biochemistry testing of biopharmaceutical products manufactured including the analytical method qualification/validation activities for all the necessary biochemistry and protein chemistry assays. This role will also support the execution of other quality control tests that are required by customers for intermediates and final materials as well as the routine testing for raw materials, facilities, utilities, and manufacturing systems as applicable. The products the site is producing are living organisms, and this role will help test and study the molecular structure and cell function.

What will you do?

- Lead the execution of Biochemistry and protein chemistry testing of biopharmaceutical products and responsible for the execution of all related operational tasks

- Plan and undertake tests to study, measure and understand the customers’ pharmaceutical product

- Support team with designing and conducting tests, making scientific measurements and capturing analytical data throughout the testing process

- Assure timely and scientifically sound output of the biochemists according to the international regulatory requirements and cGMP

- The execution and delivery of biochemistry and other chemistry results necessary for the release of biopharmaceutical products for clinical and commercial use.

- Ensure compliance of facilities, product and systems with international quality requirements and in line with the customer specific requirements

- Direct engagement with regulatory inspections including preparation, management and response development.

- Subject Matter Expert (SME) in explaining the scientific justification and equipment used in the biochemistry and protein chemistry testing involved in the release of biopharmaceutical products manufactured.

- All managerial responsibilities for the achievement of department objectives, including hiring, training, coaching and mentoring professional staff on biochemistry testing and the technical transfer of analytical methods in support of associated biochemistry and protein chemistry testing.

- Practical application of various risk assessment tools

- Practical application of the Quality System (Change Control, Deviation, CAPA, OOS and OOT, Document Management, related to the QC department)

- Management of Unexpected, OOT and OOS results generated by the Laboratory and externally contracted laboratories.

- Procurement, commissioning, and implementation of state-of-the-art testing equipment in support of biochemistry (protein chemistry) and other chemistry assays in support of quality control testing of biopharmaceutical products

How will you get here?

Education Skills and Experience

- Hold a Bachelor of Science (biochemistry, chemistry, biology) and or Masters or Post Graduate qualifications- beneficial

- Demonstrated significant biopharmaceutical manufacturing industry, including experience and expertise in biochemistry and chemistry assays

- Previous experience working in Contract Manufacturing Organisations (CMOs)

- Good knowledge of current Good Manufacturing Practices (cGMP)

- Knowledgeable on laboratory testing, efficient sample flows, release of raw materials, in process controls and drug substance testing, and area/ equipment in Quality Control

- Experience with client audits/ regulatory inspections

- Previous leadership experience

- Familiarity with principles of aseptic techniques

What would 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

- Demonstrates the ability to work independently and manage planned work.

- Ability to work on multiple projects or tasks simultaneously

- Demonstrates the ability to deliver on promises made to customers, i.e. meet agreed due dates

- Ability to interpret and apply GMP principles, strong attention to detail and accurate completion of test records

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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