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 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 point 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 PropositionEmployees 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.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. RequirementsResponsibilities: The Specialist will be required to lead, collaborate and facilitate running
of activities (e.g. scale- up, 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 on- time 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,
multi-skilled 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 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 levelsParticipate 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 PatientsFocus the entire organization on delivering value for
customers, including patients, by understanding and meeting their needs.CollaborateActively listen and seek to understand differing
perspectives; work together to achieve the common goals of the client. Demonstrate
Inclusion and Leader behavioursAct with Candor and CourageSpeak openly, honestly and with conviction; have the
courage to take appropriate risks and make difficult decisions.Make Rapid, Disciplined DecisionsMake timely decisions at the right level with the right
data, and support them once made.Drive ResultsSet 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 & IntegrityAdhere 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
environmentDemonstrated knowledge in pharmaceutical /
biopharmaceutical technical / manufacturing operations.Experience of involvement in a technical project an
advantageKnowledge 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 principlesProject management qualification such as, Project
Management Professional is desirableEvidence 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 non-performers.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#LI-XA1