Lead Analytical Development Specialist
A challenging opportunity has arisen for a Lead Analytical Development Specialist to join our team. In this role, you will be responsible for leading the development and refinement of analytical methods.
About the Role
* Method Development: Design, develop, and improve analytical methods to support product development, ensuring compliance with regulatory requirements.
* Tech Transfer Expertise: Provide technical guidance on resolving complex challenges and facilitating technology transfers between teams.
* Project Coordination: Develop project plans to align analytical validation efforts with broader development timelines, ensuring seamless execution.
* Routine Testing: Oversee routine testing to support product development, guaranteeing accurate results and data integrity.
* Risk Assessment: Lead risk assessments to ensure adherence to relevant regulatory standards and minimize potential risks.
* Mentorship: Mentor and guide team members to foster a collaborative and productive environment, promoting knowledge sharing and skill development.
* Recommendations: Deliver clear and actionable recommendations to inform technical strategies and decisions, driving business growth and excellence.
* Quality Control: Review and approve work completed by team members, including validation data and testing reports, ensuring compliance with quality standards.
* Documentation: Maintain thorough and compliant documentation for all processes and results, facilitating knowledge management and continuous improvement.
Requirements
* Bachelor's degree in Chemistry, Analytical Science, or a closely related field.
* Significant experience in developing and validating analytical methods, with a strong understanding of ICH guidelines and GMP standards.
* Proven leadership or supervisory experience within a technical setting, with a track record of delivering high-quality results.
* At least four years of experience in analytical development within the pharmaceutical or medical device industry, with expertise in regulated environments.
Key Skills
* Strong problem-solving skills with a proactive approach to challenges.
* Excellent written and verbal communication abilities, with a focus on clarity and concision.
* A team player who can build positive working relationships and foster collaboration, driving business success and employee engagement.
* Demonstrates a strong commitment to quality and delivering exceptional results, with a customer-centric mindset.
* Organized and detail-oriented, with the ability to manage multiple tasks effectively and prioritize projects accordingly.
About You
You are a dedicated and innovative professional with a passion for analytical development. Your expertise and leadership skills enable you to manage complex projects and mentor your team to achieve exceptional results.
Your academic background in chemistry or analytical sciences, combined with hands-on experience in regulated environments, provides you with the expertise to excel in this role. Your understanding of compliance and quality standards ensures success in delivering high-quality outcomes.
About the Opportunity
This is an exciting opportunity to join a forward-thinking organization that values diversity, inclusion, and innovation. We offer opportunities to work on impactful projects in a cutting-edge field, a supportive and growth-oriented work culture, and a competitive compensation package.
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