Join to apply for the Senior Bioprocess Scientist role at Thermo Fisher Scientific.
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed
Laboratory Setting
No contact lens allowed; prescriptive glasses will be provided
Office
Some PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Standing for full shift
Work Schedule
10 hr shift/days
About Us
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This role sits within the Upstream (USP) team within Operations and is based at our Brisbane site. The site carries out manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, and other regulatory bodies. This role is based on site and does require shift working.
What You'll Do
Key Responsibilities
Train and mentor junior staff to build a successful team and plan for future talent growth.
Ensure PAI readiness within USP by identifying and addressing gaps, as well as leading preparation of story boards to support audits.
Identify the implementation and validation (IOPQ) for 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, including collaboration outside BU with other business units.
Apply principles, theory, and strategy for business success, emphasizing lean manufacturing and PPI. Lead team in continuous improvement culture.
Develop onboarding and training programs for new USP staff, with the ability to roll out across OPS teams.
Maintain training on all USP processes and equipment, and keep training matrix up to date.
Train co-workers on specific equipment and approve on-the-job trainings.
Deliver improvements in site KPIs like Right the First Time and On Time Delivery.
Deputise for the USP Manager/Supervisor when needed, demonstrating leadership and accountability.
Prioritize and complete USP operations in a clean room environment under cGMP conditions.
Support USP functions, including maintaining production suite, supplies, equipment, logbooks, data, and batch record closing.
Perform equipment testing and troubleshooting.
Review, revise, and author manufacturing batch records, SOPs, and logbooks.
Collaborate with Quality to review and sign off batch records, act as lead investigator for deviations.
Propose and implement corrective actions, and drive closure of deviation reports and change controls.
Identify practical problems, propose solutions, and implement lean initiatives and continuous improvements.
Lead transfer of new technologies, procedures, and equipment.
Liaise with suppliers on technical issues.
Write, review, and complete validation protocols.
Implement cGMP Quality Management System and EH&S requirements.
Keys to Success
Education
Tertiary Education in Science or Engineering (e.g., biopharmaceutical manufacture, biotechnology, process technology) and/or equivalent work experience.
Skills & Experience
At least 4 years' industry experience in bio/pharmaceutical fields.
Extensive experience in a cGMP environment.
Knowledge of relevant quality systems.
Skills in influencing decision-making with a continuous improvement approach.
Strong interpersonal, communication, organization, and planning skills.
Responsible and proactive attitude.
Benefits
Health & wellbeing benefits, wellness programs, and support services.
Flexible work arrangements.
Generous leave policies, including paid birthday leave and parental leave.
Paid volunteer time and charitable support.
Opportunities for learning and career development via online courses, workshops, and mentorship.
Our Mission & Values
We aim to enable our customers to make the world healthier, cleaner, and safer. Join our diverse team of 100,000+ colleagues sharing values of Integrity, Intensity, Innovation, and Involvement. We support research, scientific challenges, technological innovation, and patient support.
Apply Today
Visit http://jobs.thermofisher.com to apply.
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