Dsp Senior Bioprocess Scientist

vor 1 Monat

Brisbane, Österreich Thermo Fisher Scientific Vollzeit

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 Brisbane Drug Substance Division is one of the five divisions that make up the Pharma Services Group.
At the Brisbane site, we specialise in current Good Manufacturing Practice (cGMP) of large-molecule biologics for both clinical research and commercials, applying powerful single-use technologies and validated manufacturing approaches.
This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally.
The network of Patheon's drug substance manufacturing sites includes St. Louis (USA), Groningen (Netherlands), and Brisbane (Australia).
About the Role:
As we see the growth of the Brisbane site, the role of Senior Bioprocess Scientists in Downstream Processing (DSP) within the Operations group has been opened due to internal movement to support the sustainable growth of DSP through the next phase of the Operations group evolution.
In this role, you will have the opportunity to demonstrate your knowledge, skills and abilities in working as a team to complete DSP unit operations, including chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration and drug substance final fill.
What You'll do: Independently perform DSP unit operations with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.Identify practical problems and communicate to the responsible person with a proactive attitude and personal initiative.Contribute to their DSP functions, such as maintaining the production suite, supplies, equipment, logbooks, and data, closing out batch records, and material reconciliation in accordance with site SOPs and policies.Perform equipment maintenance and testing related to the technical skills of DSP Senior Bioprocess Scientist.
Support and implement new procedures and/or equipment in the OPS department in consultation with other owners and users.Revise and author batch records, SOPs and logbooks.Complete validation protocols for which a DSP Bioprocess Scientist skill is required.Adhere to the Patheon cGMP Quality Management System and the Patheon EH&S requirements.Contribute to minor and major deviations by becoming the lead investigator.
Propose and implement corrective and preventive actions.
Ensure timely closure of deviation reports and change controls.Implement lean (OE) initiatives and continuous improvements.Contribute to the transfer and understanding of specific new technologies to DSP.Connect with suppliers about issues of a technical nature.Keys to Success: Education:
Tertiary education in a science or engineering-based field (i.e.
biopharmaceutical manufacture, biotechnology, chemical/biochemical/bioprocess/biomolecular engineering, process technology).
Experience:
Two years of proven practical experience in a Biopharmaceutical cGMP manufacturing environment.
Specific knowledge of DSP processing within cGMP/GLP regulations in cGMP/cGLP manufacturing environment, including chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration, or drug substance final fill.
Knowledge, Skills, Abilities:
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 (Environment, Health & Safety) and cGMP compliance.
Due to involvement in the timely execution of manufacturing processes, a fair amount of organization, flexibility in working hours, and proficiency in working with the team are crucial.
Ability to work unsupervised.
Good communication, flexibility, reliability, and assertiveness.
Responsible and proactive.
Physical Requirements / Work Environment:
Able to lift 40 lbs.
without assistance.
Require to work on shift, with the remuneration provided as per the Company's policy.
Adhere to standard GMP Cleanroom: hair products, jewellery, makeup, nail polish, perfume, exposed piercings, facial hair, etc, are prohibited.
Some degree of PPE (Personal Protective Equipment) is required, including safety glasses, gowning, gloves, lab coat, ear plugs, etc.
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, including inspections and risk assessments, as advised.
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 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.
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