USP Team Leader

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:

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
The role sits within the Upstream (USP) team at our Brisbane site which is focused on the manufacture of biopharmaceutical products in compliance with international quality requirements set by TGA, FDA, EMEA, ICH, and other regulatory bodies.

About the Role:
The USP Team Lead will join an existing team and manage a team of 4 direct reports. 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 EHS and cGMP.

What You'll Do:
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 EHS 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 a technical nature
Keys to Success:
Education:
Tertiary education in science or engineering based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology)
Skills and Experience:
At least 3 years of relevant industry work experience within the bio (pharmaceutical) fields
Very good knowledge and experience working within 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.
Due to involvement in the timely execution of manufacturing processes, interpersonal and organisational skills and flexibility in working hours are required.

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

Health Wellbeing: Join a company that prioritizes your health wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
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, solve complex 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. Read more