MST Bioprocess Lead - Hybrid

About PSC Biotech

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 serving 350 clients in more than 23 countries worldwide. We provide cloudbased 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 point which includes the opportunity to work with the most talented cohort of likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.

Overview:

MS&T Bioprocess lead supports the development of the site providing leadership and Drug Substance technical support in the Process Sciences Laboratory. Leads/participates in cross functional teams to deliver all project and investigational activities on schedule. The successful candidate will develop a talented team of Manufacturing Science & Technology Scientists in delivery of new products for commercial operations.
Hybrid model potentially 2 days remote working

Requirements

Responsibilities:

• Reporting to the Manufacturing Science & Technology Laboratory Lead the responsibilities include but are not limited to the following:
  
• Manage coach and mentor the MS&T drug substance team in performing advanced technical experiments. Inspire reward and develop individuals helping them to reach their potential.
  
• Technical Lead for MS&T Process Sciences and the site.
  
• To provide proactive technical oversight of the biologics inline & pipeline products.
  
• Lead technical assessments for process investigations risk assessments evaluation of specifications and material qualification.
  
• Coach the team on development and of technical studies continuous improvement of existing biologics processes and for new product launch.
  
• Complete experimental design data analysis and interpretation for improvement programs.
  
• Oversight of the product robustness trends observed in commercial operations and alignment with laboratory models such as SIMCA for multivariate data analyses.
  
• Lead and/or support deployment and use of various digital tools at the facility: Leverage these tools to deliver business value through predictive/proactive issue resolution rapid investigation closure improved yield/throughput.
  
• Assist in the regulatory authoring and review of technical documentation technical report writing and global regulatory submissions.
  
• Support creation of the laboratory budget and review actual performance against forecast.
  

Skills & Education Required:

• Ideally a Master s in Biological Sciences/ Chemical Engineering/ Biological Engineering/Chemistry.
  
• 8 years directly related working knowledge in academia pharmaceutical or biotechnology company along with a working familiarity of current regulatory requirements and current Good Manufacturing Practices.
  
• The successful candidate will also have demonstrated the ability to deliver projects and programs with a strong understanding of lean and laboratory operations.
  
• Excellent oral and written communication skills with the ability to effectively articulate understanding of process science to drive decision making impact assessments design of studies in a multidisciplinary team environment.
  

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