Senior Technical Support Specialist – Drug Substance
Join PSC Biotech® Corporation to apply for the Senior Technical Support Specialist – Drug Substance role.
About PSC Biotech: 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, serving 350 clients in more than 23 countries worldwide. We provide cloud‑based software solutions for Quality Management and Regulatory Inspections, pharmaceutical contract manufacturing professionals, and metrology services to our clients.
Responsibilities
Provide Technical Support within the Drug Substance manufacturing team including areas such as Cell expansion, Bioreactor and Downstream.
Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
Coordinate technical deliverables within Drug Substance to support the successful product launch.
Provide technical support to the operations team’s during commercial manufacturing.
Lead/participate in manufacturing investigations with cross‑functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
Support Batch Disposition activities by providing SME technical support for comment resolution.
Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance.
Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organization.
Requirements
Minimum 3 years working in a biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.
Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
Experience in a risk‑based approach to manufacturing through use of tools such as FMEA.
Ability to adapt to changing priorities as project demands change.
Education
Bachelor of Engineering or Science Degree in Engineering or Science related discipline.
Other Skills, Abilities & Experience
Previous experience in an operations role within vaccine manufacturing preferred.
Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirable.
Experience in DS process such as cell culture, downstream processes.
Experience in start‑up facility advantageous.
Demonstrated excellence in planning and organizational skills.
Demonstrated skills in communication (oral and written) & in particular technical writing.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Information Technology
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