Technical Support Scientist – Fill Finish
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia and the US. We serve 350 clients in more than 23 countries worldwide, providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.
Employee Value Proposition
We disrupt the conventional consultancy model by aligning our value proposition as a unique selling point, offering permanent contracts and exposure to top pharmaceutical client sites in a diverse‑cultural environment. Our focus is on empowering career development through in‑house training, mentorship, and constant guidance to facilitate progression.
Responsibilities
* Provide technical leadership within the drug product manufacturing team (Formulation, Filling, Lyophilisation, Capping, and Automated Visual Inspection).
* Execute equipment qualification deliverables during the project phase (Commissioning & Qualification, IOQ).
* Coordinate technical deliverables to support successful product launch.
* Provide technical support to the operations team during commercial manufacturing.
* Lead or participate in manufacturing investigations with cross‑functional teams to ensure root cause analysis and appropriate CAPAs are implemented.
* Support batch disposition activities by providing SME technical support for comment resolution.
* Identify and implement projects to continuously improve compliance and manufacturing capabilities.
* Support continuous process and quality improvements through Lean Six Sigma tools.
* Create and revise technical documents (batch records, SOPs, technical memos).
* Collaborate with the site MS&T scientist to provide comprehensive technical leadership to the DP organization.
* Participate in regulatory, client, and internal audits as the technical representative.
* Act as delegate for the Manufacturing Technical Lead.
Requirements
* Minimum 5 years working in a biological, vaccine or pharma facility, preferably with cGMP sterile manufacturing experience.
* Ability to operate within a matrix team to execute floor activities such as FAT, SAT, IQ/OQ, and engineering batches.
* Experience with data‑driven root cause analysis and prioritization of continuous improvement initiatives (e.g., Six Sigma).
* Experience leading and resolving complex technical investigations.
* Experience in a risk‑based approach to manufacturing using tools such as FMEA.
* Ability to adapt to changing priorities as project demands evolve.
Education
* Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
Other Skills
* Previous experience in an operations role within vaccine manufacturing preferred.
* Knowledge of USP1790 and industry/regulatory requirements such as Annex 1 desirable.
* Ability to explain complex technical issues to external customers or agencies.
* Experience with lyophilized products advantageous.
* Experience in start‑up facilities advantageous.
* Demonstrated excellence in planning and organizational skills.
* Strong oral and written communication skills, particularly technical writing.
Seniority level
* Mid‑Senior level
Employment type
* Full‑time
Job function
* Research, Analyst, and Information Technology
#J-18808-Ljbffr