Scientific Technical Specialist

Job Title: Scientific Technical Specialist

Purpose of Role:

This position will provide technical support to the Vaccines IPT to support the technology transfer and scaleup of new processes for Vaccines IPT manufacture meeting the client Manufacturing Division Priorities of: Compliance Supply HPO Strategy and Profit Plan.

Requirements

Activities Within Role:

The Specialist will be required to lead collaborate and facilitate running of activities (e.g. scaleup PPQ batch manufacture licence submissions and audit readiness) in the Vaccines IPT value stream for Technology Transfer of processes to ensure the effective and efficient ontime delivery of these activities to Vaccines IPT.

This requires the delivery of technical excellence to deliver components of a stable process supported by a flexible collaborative multiskilled teamwork environment.

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 highquality 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 crossfunctional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.

Participate and comply with the client 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.

Reports to:

Vaccine Technology Transfer Lead Technical Operations

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 client 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:

Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.

4 plus years experience in biopharmaceutical/vaccines environment

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.