Analytical Sciences & Technology Manager
* Location: Waterford
* Job type: Fixed Term 23 months
About the job
Our Team:
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Working Relationship
* Key Internal Contacts: Senior Leadership Team (SLT), Extended Leadership Team (ELT), QA Department, QC Department, Validation, Program Managers
* Key External Contacts: Research & Development, Clinical, Regulatory groups, Manufacturing Sciences and technology (MSAT) groups, SME’s
Purpose of Role
* Leads the Analytical Sciences & Technology department
* Co-ordinates external communication to the wider network
* Centre of excellence mandate – maintain cutting edge science and technology and influence site strategy and investment based on sound science
Main responsibilities:
* Develop a technical roadmap for both career development and site capability across the analytical spectrum
* Maintain and develop new network relationships based on product portfolio (now and in the future)
* Accountable for delivering Method Transfers, development to validation
* Accountable for delivery of the site ALCM process
* Provide inputs into the QC annual capital program planning based on horizon projects in the network
* Enable AST method knowledge support to QC and manufacturing for investigations and deviations
* Manage AST spend to budget
* Manage departmental goals & objectives to enable site strategic business objectives
* Identify and implement CI projects in support of improved ways of working
* Establish and maintain a comprehensive always audit readiness plan for analytical sciences group
* Ensure laboratory areas meet current Good Laboratory Practices (cGLP) requirements
* Ensure relevant procedures are correctly defined and followed
* Ensure that critical chemical testing and related equipment meets current validation requirements (IQ/OQ/PQ) where required
* Ensure safety & compliance standards are maintained to the highest standard
* Maintain internal / external audit ready standards.
* Maintain training compliance
About you
* Minimum degree in Science (Chemistry or Biochemistry preferred)
* Ideally – MSc or PhD in a relevant discipline
* 10+ years’ experience should be in a laboratory environment – ideally part of which would be in the pharma or biopharma sector
* Excellent leadership skills with ability to influence and affect change
* Detailed knowledge of Biopharma analytical methodologies and technologies
* Deep understanding of requirements for cGXP, ICH requirements and pharmacopoeia methods
* Understanding of current regulatory requirements and trends
* Ability to manage projects to plan/budget
* Excellent & efficient communicator at organisation, team and individual levels
* High energy, commitment and flexibility
* Advanced problem-solving skills in a technical environment
* Ability to develop a high performing organisation interpret site strategies into executable plans
* Comfortable leading across multiple stakeholders & multinational teams
Why choose us?
* Bring the miracles of science to life alongside a supportive, future-focused team
* Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
* Play an instrumental part in creating best practice within our manufacturing facility
* Our Waterford site is easily accessible from the M9 and offers excellent facilities including a subsidized restaurant and newly refurbished gym
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