Senior Laboratory Manager
Job ID: JOB-12361
Senior Laboratory Manager
We are looking to speak with experienced Chemistry Managers about this great new job opportunity in Galway with one of our leading clients? This company stands out for their culture, exceptional career development pathways and unrivalled rewards and recognition packages. This exciting new job opportunity in Chemistry Management is located in Galway. Please note that there will be a requirement ro work for the initial 3-6 months in the States as you will be working on a new laboratory that is being set up and transferred from California.
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Apply to us to find out more about this great job opportunity in R&D Engineering in Galway and we can talk through if it’s the right job for you.
The Senior Chemistry Manager will be responsible for leading a workgroup of managers/supervisors, chemists and scientists, and technicians who perform testing studies supporting regulatory submissions, including ISO 10993-18, EU MDR, MD SOTA, and material of concern for an Analytical Chemistry laboratory within a regulated medical device industry. The position has responsibility for people management, seamless partnership with teams supporting the entire biocompatibility lifecycle, collaborating with the clients to understand testing needs and define testing plans, providing work direction to analysts, work prioritization, data and report review, and leading lab improvement projects. The position will also partner with lab leaders in other geographies to ensure standardization, and with leadership on strategic planning.
A Day in The Life Of:
- Manage and coordinate the day-to-day activities of the workgroup including work direction, prioritization, and training.
- Work seamlessly with peer organizations to ensure technically sound, timely, and compliant regulatory submissions.
- Partner with the lab’s clients to define testing needs, priority, and resource planning.
- Perform detailed technical and quality review and approval of lab notebook entries and reports.
- Author, review and/or approve laboratory reports, test methods, and standard operating procedures (SOPs).
- Partner with lab quality on an ISO 17025 quality system and ensure compliance to department processes
- Manage department metrics and own/drive countermeasures when needed.
- Provide support for lab quality activities including Out of Specification investigations, CAPAs, audits and inspections.
- Lead lab improvement projects with a focus on improving client support levels and increasing operational efficiency.
- Manage change by developing materials and facilitating meetings to gain employee feedback, inform employees, influence behavior, drive decisions, and set policies.
- Provide performance feedback and career development through regular mentoring and coaching.
- Hire top candidates and help them successfully integrate into the department.
Key Skills & Experience
- Strong chromatography (liquid and gas) and mass spectroscopy experience and expertise.
- Demonstrated technical leadership skills in defining test plans, data interpretation, and providing technical recommendations to project teams.
- Record of developing and maintaining strong working relationships with internal and external stakeholders to influence the outcome of important decisions or initiatives.
- Experience managing change, managing/leading others, coaching and providing performance feedback.
- Proficiency authoring and editing technical reports, business correspondence and quality systems procedures.
- Ability to effectively present information and respond to questions from groups of executives, managers, and clients.
- Quality, reliability, or other regulated industry experience, including knowledge of ISO 17025, cGMPs, and 21CFR11.
- Experience working across organizations to achieve business goals.
- Excellent interpersonal, verbal, training, and presentation skills.
- 10+ Year’s lab experience with Bachelors’ degree Level 8 minimum or 8+ years with advanced degree, including 5+ years of people and/or project management experience.
- Masters degree in Chemistry, Materials Science, Physics, Engineering, or related technical discipline.
- Expertise with ISO 10993, especially part 18, EU MDR chemistry testing, MD SOTA chemistry testing is essential
- Expert in testing of medical device for leachable and extractables using one or more techniques of GCMS, LCMS and ICPMS.
- Expertise in liquid and chromatography method development and validation.
- Experience developing budgets and managing departmental costs.
- Experience leading Lean or Six Sigma projects and/or project portfolios.
- Experience and knowledge in Project Management.
- Experience with Medical Device Industry and products is essential
For further information on this role in Galway please contact Caroline Kingston on +353 868395531 or email email@example.com Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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