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, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift Job Description At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world. Job Role, Team / Function, Band Level Bioprocess Scientist – DSP – Band 3 Reports to DSP Team Leader Responsibilities: · 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 · Ensure compliant execution of DSP manufacturing activities under cGMP conditions · Maintain high standards of data integrity, documentation accuracy, and traceability · Take ownership of production area readiness including equipment, materials, and documentation · Proactively identify, communicate, and help resolve operational issues · Ensure equipment is maintained, functional, and fit for purpose · Contribute to continuous improvement and operational efficiency initiatives · Support implementation and understanding of new technologies within DSP · Adhere to Thermo Fisher Scientific cGMP Quality Management System requirements · Comply with Environmental Health & Safety (EH&S) policies and procedures · Support quality systems including deviations, CAPA, and change control processes · Maintain effective communication with internal stakeholders and external suppliers Minimum Requirements/Qualifications: Qualifications & Experience: · Either experience in pharmaceutical industry OR tertiary education in science or engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology). · Good understanding of cGMP practices. Skills & Attributes: · Ability to work unsupervised. · Good communication, flexibility, reliability and assertiveness. · Responsible and proactive. Other Job Requirements: Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment Adhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law 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. 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.