Process Scientist

About PSC Biotech

PSC Biotech is an established biotechnology consulting firm founded in 1996 and based in Pomona, California, with global presence including Ireland, India, Singapore, Australia, and the USA. Serving over 350 clients in more than 23 countries, PSC Biotech specializes in cloud-based quality management software, regulatory inspection support, pharmaceutical contract manufacturing, and metrology services.

Employee Value Proposition

PSC Biotech offers a permanent contract with exposure to top pharmaceutical clients in a culturally diverse environment. Employees benefit from robust career development through in-house training, mentorship, and continuous guidance, fostering high-performing teams that meet quality, budget, and timeline goals effectively.

Role Overview

The Process Scientist will hold a pivotal role within the vaccine manufacturing MSAT laboratory, providing critical support to upstream and downstream process experiments at lab scale. This includes leading and managing studies involving cell culture, bioreactor operation, and downstream processing like tangential flow filtration and clarification.

Key Responsibilities

• Lead and assist small-scale upstream and downstream studies within the MSAT lab.
• Operate and manage cell culture seed trains and bioreactor setups to ensure smooth processing.
• Execute downstream processes including tangential flow filtration, clarification, filtration, and drug substance dilution.
• Develop and maintain a thorough understanding of upstream/downstream process development and scale-down models.
• Create detailed reports and present data to internal teams.
• Demonstrate flexibility to support weekend laboratory work as necessary.
• Assist manufacturing teams during engineering, validation, or clinical batch studies.
• Support vaccine process satellite runs to guarantee efficient and consistent vaccine production.
• Ensure accurate record-keeping and documentation in compliance with GLP standards.
• Contribute to drafting and revising SOPs, protocols, MBRs, technical memos, and other related documentation.
• Exhibit expert knowledge of vaccine drug substance processes, including critical attributes and specifications.
• Collaborate with MSAT and drug substance technical teams to provide technical leadership and guidance.
• Support equipment qualification during project phases, including commissioning and installation qualification.
• Identify and implement continuous improvement projects to enhance compliance and manufacturing capabilities within the MSAT lab.

Qualifications and Experience

• Master's or Bachelor's degree in Biology, Biotechnology, Microbiology, Chemistry, Pharmaceutical Engineering, or related disciplines (or equivalent experience).
• At least 2 to 3 years of experience in biological or vaccine clinical/commercial manufacturing.
• Proven background in cell culture process development and bioreactor operations.
• Experience in downstream process development relevant to bioprocessing.
• Proficient in bioprocess development, biopharmaceutical production, and biological process validation, with a record of successful execution.
• Preferred experience in biological production process validation and familiarity with biopharmaceutical cGMP quality systems.
• Strong communication skills for clear oral presentations in both internal and external meetings.
• Excellent organizational skills to manage and track project progress.
• Experience with troubleshooting process deviations, risk analysis, technical transfers, and process validation execution.

Additional Details

This is an 11-month maternity cover contract position based on-site in Dundalk, County Louth, Ireland.