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, Cold Room/Freezers -22degrees, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
About Us:
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer! Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com
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Position Summary:
We're looking for a USP Team Lead to join our team! The Upstream (USP) team at our Brisbane site manufactures biopharmaceutical products in compliance with international quality requirements set by TGA, FDA, EMEA, ICH, and other regulatory bodies. If this aligns with your experience, we encourage you to apply!
Key Responsibilities:
- Foster and develop a hard-working team through effective coaching and leadership.
- Ensure growth and development of the USP team with a focus on building talent depth.
- Deliver sustained improvement in the site key performance indicators of Right the First Time and On Time Delivery.
- Deputise for the USP Supervisor when they cannot be present as well as demonstrate leadership and accountability.
- Contribute to the direction of site operations and ensure the use of new and innovative processing techniques, such as Perfusion technology, Bioreactor technology, and advanced harvesting methods like single-use centrifugation.
- Communicate effectively in a variety of communication settings; provide timely and helpful information to others across the organization; encourage others to contribute ideas and opinions.
- Possess a high level of independence along with a recognised sound and consistent approach when facing technical or personnel problems.
- Independently organize and complete USP unit operations following the relevant production protocols and planning schedules in a clean room environment under cGMP conditions.
- Identify and overcome practical problems, proposes possible solution and communicates to the responsible person.
- Support USP and facility functions by maintaining production suite, supplies, equipment, logbooks, and data. Also responsible for closing out batch record and material reconciliation following site SOPs and policies.
- Review, revise, and author manufacturing batch records, SOPs, and logbooks. Collaborate with the Quality Department to review and approve completed batch records.
- Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements. Be the lead investigator for minor and major deviation reports.
- Be fully trained on all USP unit operations and equipment as well as maintain up to date training matrix.
- Train colleagues on unfamiliar unit operations or equipment, including approving on-the-job trainings.
- Propose and implement corrective and preventive actions and drive the on-time closure of deviation reports and change controls.
- Implement lean (OE) initiatives and continuous improvements with minimal direction.
- Communicate with suppliers about issues of technical nature.
Skills and Experience:
- Tertiary education in science or engineering based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology)
- At least 3 years of relevant experience in the bio (pharmaceutical) fields.
- Very good knowledge and 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 bioprocess unit operations
- Strong organisational, scheduling and planning skills.
- Ability to work unsupervised.
- Good communication, flexibility, reliability and assertiveness.
- Responsible and proactive.
The Brisbane site of Thermo Fisher Scientific produces various products for clinical trials and commercial use. There are many different processing steps for each product due to the diverse range of customers. The Team Leader must be able to assess the impact of situations on product quality, yield, and compliance with EH&S and cGMP.
Due to involvement in the timely execution of manufacturing processes, interpersonal and organisational skills and flexibility in working hours are required.
Employee Benefits:
- A competitive salary and performance related bonus structure
- Access to Thermo Fisher's global University
- Exposure to market leading & innovative technologies
- Career development opportunities in a leading global organization
We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. Watch as our colleagues explain 5 reasons to work with us.
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.