A leading multi-national client are looking for a highly experienced Senior Chemistry Manager to join their team. 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 behaviour, 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
- Knowledge of Quality System Regulations in the areas of Chemical Testing, Laboratory Investigations and CAPA.
For a more detailed and confidential discussion on this role contact Amy Newell.