DSP Bioprocess Scientist

Job description

Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description 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. About the Role:Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by relevant authority. What You'll Do:Execute DSP unit operations including chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration, and drug substance final fill in accordance with approved protocols Follow production schedules, batch records, and SOPs in a cleanroom cGMP environment Monitor processes and identify operational or technical issues during execution Escalate issues and communicate effectively with responsible personnel Maintain production suites, equipment, and supplies to ensure operational readiness Complete logbooks, batch documentation, and ensure accurate data recording Perform batch record review, closure, and material reconciliation Conduct routine equipment maintenance, calibration checks, and functional testing Troubleshoot equipment and process issues within scope of role Support implementation of new equipment and procedures within DSP operations Author, revise, and maintain SOPs, logbooks, and controlled documents Participate in deviation investigations and root cause analysis Complete corrective and preventive actions (CAPA) in a timely manner Support closure of deviations and change controls Participate in lean (Operational Excellence) initiatives and continuous improvement activities Assist in technology transfer activities and adoption of new DSP processes Communicate with suppliers/vendors to resolve technical issues EducationTertiary education in science or engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology) preferred ExperienceExperience in pharmaceutical industry Good understanding of cGMP practices. Knowledge, Skills, AbilitiesAbility to work unsupervised. Good communication, flexibility, reliability and assertiveness. Responsible and proactive. Other Important Information Adhere to OHS 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. Should this be a requirement of your position, you will be remunerated per the Company’s policy. BenefitsJoin 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 125,000+ 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. 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.