Specialist - Vaccines Technology Transfer Technical Operations

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.

Requirements

Primary activities/responsibilities:

• Ensure the highest Quality Compliance and Safety standards primarily with Technology Transfer but relating to all activities.
  
• Work within a team to enable the team s performance within the Vaccine Technology Transfer group in the Technical Operations Dept.
  
• Responsible for the technical transfer and scale up of a new process into Vaccines IPT.
  
• Input into Technical planning and decisions for the Vaccines IPT to ensure supply of high quality product through tactical planning and execution of production schedules.
  
• Technical Review ownership of and approval of Change Control Quality Notification deviation and investigation records as required.
  
• Recommend technical approaches in line with global and local standards.
  
• Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  
• Contribute for driving a culture of Continuous Improvement by deploying MPS within the IPT on projects such as: problem solving reducing cycle time Lean principles within the new processes.
  
• Stakeholder management of multiple decision makers corporate colleagues cross functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
  
• Participate and comply with the Quality Management System (QMS) requirements including ownership as relevant.
  
• Continuous Improvements: Responsible for supporting a culture of Continuous Improvement by championing problem solving tools within Technology Transfer for Vaccines IPT.
  
• Coaching and Training: Model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
  
  

Key Behaviours:

• Focus on Customers Including Patients
  
• Focus the entire organization on delivering value for customers including patients by understanding and meeting their needs.
  
• Collaborate
  
• Actively listen and seek to understand differing perspectives; work together to achieve the common goals of MSD. Demonstrate Inclusion and Leader behaviours
  
• Act with Candor and Courage
  
• Speak openly honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.
  
• Make Rapid Disciplined Decisions
  
• Make timely decisions at the right level with the right data and support them once made.
  
• Drive Results
  
• Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Develop work relationships and influence colleagues across the value stream to achieve goals and remove barriers.
  
• Demonstrate Ethics & Integrity
  
• Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws policies and regulations; identify and address ethical issues without hesitation.
  
• Build Talent: Build diverse talent with the capabilities necessary to succeed in our markets; inspire reward and develop to ensure individuals reach their potential; make tough calls when necessary.
  

Job Experience:

• > 4 years experience in biopharmaceutical/vaccines environment
  
• Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
  
• Experience of involvement in a technical project an advantage
  
• Knowledge of Regulations and applicable standards for Quality Safety Regulatory within the biopharmaceutical/vaccine area.
  

Qualifications:

• Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
  
• Preference for Lean Six Sigma qualification or experience of application of Lean principles
  
• Project management qualification such as Project Management Professional is desirable
  
• Evidence of Continuous Professional Development
  
  

Skill Set:

• Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing technology validation engineering quality.).
  
• Demonstrated ability in holding project team members responsible for results and being decisive about nonperformers.
  
• Demonstrated ability to realize improvement initiatives.
  
• Demonstrated successes in a team environment such as project teams.
  
• Demonstrated high level of problem solving and facilitation skills.
  
• Advanced PC skills such as Excel Word PowerPoint.
  
• Stakeholder management of multi decision makers colleagues peers and cross functional teams.
  
• Experience in a FDA / HPRA Regulated production environment.
  

Reports to: Vaccine Technology Transfer Lead Technical Operations