Specialist - Vaccines Technology Transfer, Technical Operations
6 hours ago
Specialist - Vaccines Technology Transfer, Technical Operations
- Industry: Pharma/Biotech/Clinical Research
- Work Experience: 4-5 years
- City: Cork
- State/Province: Cork
- Country: Ireland
Job Description
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, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
Overview:
This position will provide technical support to the Vaccines IPT to support the technology transfer and scale-up of new processes for Vaccines IPT manufacture meeting priorities of Compliance, Supply, HPO, Strategy, and Profit Plan.
Requirements
Responsibilities:
- Lead, collaborate, and facilitate activities (e.g., scale-up, PPQ batch manufacture, license submissions, and audit readiness) in the Vaccines IPT value stream for Technology Transfer.
- Ensure the highest Quality, Compliance, and Safety standards primarily with Technology Transfer.
- 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.
- Contribute to driving a culture of Continuous Improvement by deploying MPS within the IPT on projects such as problem-solving, reducing cycle time, and Lean principles.
- Stakeholder management of multiple decision makers, corporate colleagues, and cross-functional teams.
- Participate and comply with the Quality Management System (QMS) requirements.
- Continuous Improvements: Support a culture of Continuous Improvement by championing problem-solving tools within Technology Transfer for Vaccines IPT.
- Coaching and Training: Model Leadership behaviours and understand MPS principles to drive a culture of continuous improvement.
Key Behaviours:
- Focus on Customers, Including Patients.
- Act with Candor and Courage.
- Make Rapid, Disciplined Decisions.
- Drive Results.
- Demonstrate Ethics & Integrity.
- Build Talent: Build diverse talent with the capabilities necessary to succeed in our markets.
Job Experience:
- > 4 years’ experience in biopharmaceutical/vaccines environment.
- Demonstrated knowledge in pharmaceutical/biopharmaceutical technical/manufacturing operations.
- Experience of involvement in a technical project is 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.
- Demonstrated ability in holding project team members responsible for results.
- Demonstrated ability to realize improvement initiatives.
- Demonstrated successes in a team environment.
- Demonstrated high level of problem-solving and facilitation skills.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Experience in a FDA / HPRA Regulated production environment.
Reports to: Vaccine Technology Transfer Lead – Technical Operations
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