Work Schedule

10 hr shift/days

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 degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

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 co-ordinate performance qualifications and other validation studies required for PPQ projects in collaboration with other teams
• Support Global network operational and tech transfer initiatives. Projects can be prioritised and implemented across a multifaceted Pharma Services group (i.e. may collaborate outside BU to orthogonal business units such as viral vector services)
• Apply principles, theory, and strategy for business success, emphasizing lean manufacturing and PPI. Lead team in positive continuous improvement culture.
• Develop a strong onboarding and training program for new USP staff with ability to roll out to all of OPS teams
• Adapt communication to audience and message; actively listen; share timely information; encourage input.
• Maintain training on all USP processes and equipment as well as maintain up to date training matrix
• 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
• 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 and act as 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
• Identify and overcome practical problems, proposes possible solution and communicates to the responsible person and implement lean (OE) initiatives and continuous improvements with minimal directions
• Lead and co-ordinate the transfer of new technologies, procedures and equipment to DSP or equivalent experience 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
• Implement Patheon cGMP Quality Management System and the Patheon EH&S requirements

Keys to Success:

Education:

• Tertiary Education in Science or Engineering based field (i.e. biopharmaceutical manufacture, biotechnology, process technology) and/or equivalent work experience

Skills & Experience

• At least 4 years' industry work experience within the bio (pharmaceutical) fields
• Very good experience working within a cGMP environment
• Specific knowledge and experience in relevant quality systems
• Validated skills to influence decision making with a continuous improvement approach
• Good interpersonal capabilities - both written and verbal - plus flexibility, reliability, organisation and planning skills
• Responsible and proactive

Benefits:

Join the team and take advantage of these benefits! Apply now to learn more about the full range of benefits we offer.

• Company prioritizes your health & wellbeing with benefits, wellness programs, and support services.
• Flexibility: Balance your work and personal life with flexible arrangements.
• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.