Aseptic Process Lead
6 months ago
Who we are?
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, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Role Description:
Requirements
Role Functions:
· Provide cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines for our site. Ensure that objectives are effectively achieved, consistent with our company requirements to ensure compliance, safety and reliable supply to our customers.
· Serve as COE in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelines
· Support team member training/development needs and ensure all receive appropriate training
· Develop and maintain training programs
· Assist the team with development of objectives and ensures alignment with site goals
· Foster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process
· Provide ongoing formal and informal feedback on the Aseptic qualification of the IPT operations team
· Effectively lead the media fill (Process Simulation) development and execution
· Responsible for contributing to the Cleanroom Operation and contamination (cGMP) in the performance of day to day activities and all applicable job functions.
Experience, Knowledge & Skills:
· 3 - 5 year’s operations experience in a sterile manufacturing environment
· Demonstrated ability to coach and lead change
· Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment
· Exceptional communication/interpersonal skills and ability to communicate to multiple levels within company
Qualifications & Education:
· Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
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