Work Schedule
12 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.)
Job Description
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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Role Summary:
We're looking for an MBP Bioprocess Team Leader to join our team in Brisbane. In thisn role you'll manage a team of between 3-8 members and your focus will be managing the team related to all aspects of manufacturing of biopharmaceutical products, in compliance with site policies and procedures.
Key Responsibilities:
- Build a hard-working team through strong coaching, leadership.
- Ensure growth and development of the MBP 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.
- Deputize for the MBP Supervisor when they cannot be present as well as demonstrate leadership and accountability.
- SME who is very experienced in the formulation of media and buffer solutions.
- As an SME of several unit operations and MBP equipment, supervise, train, coach and mentor co-workers that are unfamiliar with the certain unit operation or handling of specific equipment, including approval of on-the-job training. Solid understanding of quality management systems (deviations and events, investigations and CAPAs, change control etc.).
- Support the MBP supervisor with scheduling, resource modelling and task allocation.
- Act as deputy in decision making process for MBP supervisor.
- Independently organize unit operations in accordance with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
- Perform equipment troubleshooting related to technical skills of Bioprocess Scientist IV.
- Approve, review, revise and author manufacturing production protocols
- Lead deviation investigations and change controls to streamline and improve internal processes.
- Propose and implement Corrective and Preventive Actions and support the on-time closure Deviation Reports and Change Controls as well as writing Minor Deviation Reports.
- Lead the lean (OE) initiatives and continuous improvements.
- A pro-active mentality and personal initiative is encouraged to identify and overcome practical problems, proposes a possible solution and communicates to the responsible person.
- Contribute to their Department functions, such as maintaining production suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
- Contribute to the transfer and understanding of specific new technologies to the OPS department and provide support and implementation of new procedures and/or equipment in the OPS department in consultation with other owners and users.
- Revise and assist in review and write quality GMP documentation.
- Communicate with suppliers about issues of technical nature.
- Collaborate with QA, QC, USP, DSP, MBP, Tech Transfer, VAL, ENG, EH&S and WHS as well as external auditors and customers
Skills and Requirements
- Preferably tertiary education in Science or Engineering based field (i.e. biopharmaceutical manufacture, biotechnology, process technology)
- At least 3 years' relevant industry experience in the bio (pharmaceutical) fields or similar
- Very good knowledge and working in cGMP environment and knowledge of pharmaceutical cGMP systems
- Strong background and prior experience in media/buffer formulation and aseptic practices and techniques.
- Solid understanding of quality management systems (deviations and events, investigations and CAPAs, change control etc.).
- Demonstrated leadership skills to influence and build effective teams
- Excellent planning and organizational skills and a demonstrated ability to thrive in a fast-paced environment
- Excellent oral and written communication skills, as well as social skills
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.