USP Lead Bioprocess Scientist Full-time

Job Title

Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.

This role is a full-time permanent position, based onsite at our Kent Street, Brisbane offices. It does not offer a hybrid working opportunity and does require some shiftwork. The role sits within the team focused on the manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.

Key Responsibilities:

• Fully trained and independently organise and complete upstream processing with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
• A pro-active attitude and personal initiative is expected to identify and overcome practical problems, proposes possible solution and communicates to the responsible person.
• Contribute 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 troubleshooting. Lead implementation of new procedures and/or equipment in the OPS department in consultation with other owners and users.
• Review, revise and author batch records, SOPs and logbooks.
• Complete validation protocols for which a USP Lead Bioprocess Scientist skills are required.
• As Subject Matter Expert for majority of USP unit operations or equipment, train co-workers including the approval of on-the-job trainings.
• Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements.
• Being the lead investigator for minor and major deviation, and propose and implement corrective and preventive actions, as well as ensure timely closure of deviation reports and change controls.
• Implement lean (OE) initiatives and continuous improvements with minimal directions.
• Lead the transfer and understanding of specific new technologies to USP.
• Connect with supplier about issues of technical nature.

Minimum Requirements/Qualifications:

Qualifications & Experience

• Tertiary education in science or engineering based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology).
• >2 years Experience working in cGMP environment and quality systems.
• Specific knowledge of upstream processing such as cell culture, bioreactor, depth filtration, etc.

Skills & Attributes

Ability to work unsupervised. Strong organisational and planning skills. Good communication, flexibility, reliability and assertiveness. Responsible and proactive.

Other Important Information:

The Patheon Biologics site (Part of Thermo Fisher Scientific) in Brisbane manufactures many products for clinical trials and commercial applications. This implies that the production activities range from implementing a totally new production run for the first time, to the routine production of a commercial batch. Due to the diversity of customers, and their associated products, the applicable processing steps are very diverse. Given the high value of the products and intermediates the Bioprocess Scientist has to be capable of judging the possible impact of a situation on product quality, yield, EH&S and cGMP compliance. Due to involvement in the timely execution of manufacturing processes, a fair amount of discipline, organisational skills and flexibility in working hours are required.

Other Job Requirements:

Adhere to EH&S policies and procedures and ensure a safe and healthy workplace environment. Work safely and only perform tasks if currently proficient and / or authorised. Report hazardous conditions, hazardous actions, incidents and near-miss incidents. Participate in EH&S activities (such as inspections and risk assessments) as advised.

Your position may require you to be on shift or on call. Should this be a requirement, there will be remuneration as per the Company's policy.

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