Senior Bioprocess Scientist USP

at  Thermo Fisher Scientific

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. You’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

EDUCATION

• Tertiary education in science or engineering based field (i.e. biopharmaceutical manufacture, biotechnology, process technology).

EXPERIENCE

• > 4 years of proven track record in the bio (pharmaceutical) fields.
• Very good experience working in cGMP environment.
• Specific knowledge and experience in relevant quality systems.
• Demonstrated strong leadership skills to influence and build effective teams
• Excellent planning and organizational skills
• Specific knowledge of relevant DSP unit operations as follows: Chromatography, Virus Inactivation, Virus Filtration, Ultrafiltration and Diafiltration, Drug Substance Filling

KNOWLEDGE, SKILLS, ABILITIES

• Strong organisational, scheduling and planning skills.
• Ability to work unsupervised.
• Good communication, flexibility, reliability and assertiveness.
• Responsible and proactive.

PHYSICAL REQUIREMENTS / WORK ENVIRONMENT

The Thermo Fisher Scientific site in Brisbane manufactures many products for clinical trials and commercial applications. Due to the diversity of customers, and their associated products, the applicable processing steps are very diverse. Given the high value of the products and intermediates the Team Leader has to be capable of judging the possible impact of a situation on product quality, yield, EH&S and cGMP compliance.
Due to involvement in the timely execution of manufacturing processes, interpersonal and organisational skills and flexibility in working hours are required.

• Build, cultivate and develop a successful team through mentor and training of junior Bioprocess Scientists, Team Leaders and Supervisors with a focus on building talent depth and succession planning.
• Ensure PAI readiness within USP by identifying and addressing gaps, as well as leading preparation of story boards to support audits.
• Identify and lead the implementation and validation (IOPQ) for sophisticated USP processing equipment to ensure USP equipment remains current.
• Drive and coordinate performance qualifications and other validation studies required for PPQ projects in collaboration with other teams.
• Support Global network operational and tech transfer initiatives to ensure competitive enabling projects can be prioritised and implemented across a multi-dimensional Pharma Services group (i.e. may collaborate closely outside BU to orthogonal business units such as viral vector services).
• Translates principles, theory and strategy into applied business success demonstrating lean manufacturing principles / PPI principles and guides team to operate in a positive PPI driven culture.
• Develop a strong onboarding and training program for new USP staff with ability to roll out to all of OPS teams.
• Communicates efficiently – is effective in a variety of communication settings and adjusts content and style to fit the audience and message; actively listens to others; provides timely and conducive information to others across the organization; encourages others to chip in ideas and opinions.
• Fully trained on all USP processes and equipment as well as maintain up to date training matrix.
• As the SME of majority of USP unit operation or equipment, train co-workers or handling of specific equipment, including approval of on-the-job trainings.
• Deliver sustained improvement in the site key performance indicators of Right the First Time and On Time Delivery.
• Deputise for the USP Manager/Supervisor when they cannot be present as well as demonstrate leadership and accountability.
• Independently prioritise and complete USP unit operations (pre-culture, aseptic technique, single use bioreactor execution and operation, depth filtration, single use mixers, SUB SCADA systems) with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
• Able to support in their USP functions, such as maintaining production suite, supplies, equipment, logbooks, and data, as well as closing out batch record and material reconciliation in accordance with site SOPs and policies.
• Perform equipment testing and equipment troubleshooting related to technical skills of Bioprocess Scientist IV.
• Review, revise and author manufacturing batch records, SOPs, and logbooks.
• Collaborate with Quality Department to review and signoff on completed batch records.
• Being the lead investigator for minor and major deviation reports.
• Propose and implement corrective and preventive actions and drive the on-time closure of deviation reports and change controls.
• A pro-active approach and personal initiative is expected to identify and overcome practical problems, proposes possible solution and communicates to the responsible person.
• Implement lean (OE) initiatives and continuous improvements with minimal directions.
• Lead and coordinate the transfer of new technologies/procedures/equipment to DSP in consultation with other departments.
• Liaise with suppliers about issues of technical nature.
• Write, complete and review validation protocols for which a USP Supervisor abilities is required.
• Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements