
Senior Technical Lead
2 weeks ago
We are seeking an experienced Senior Technical Lead to join our Global Device Development team. As a key member of the team, you will be responsible for leading the development of device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products.
Key Responsibilities:
- Provide subject matter expertise to support the development of Combination Products.
- Lead a team to plan and execute design verification and reliability strategies.
- Be responsible for the technical interface between drug product and device teams during combination product development.
- Develop design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
- Use statistical techniques or data analysis to inform design decision making and conclusions.
- Ensure all activities within the team are conducted and executed to the appropriate quality standards within the GDD Quality Management system.
- Lead support activities for external and internal audits and inspections as applicable.
Requirements:
- Degree in Science/Engineering (Master's preferred).
- Proven experience in pharmaceutical and/or medical device development.
- Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
- Experience in the development and validation of analytical methods.
- Experienced in the application of statistical techniques for data analysis.
- Experience of writing and supporting regulatory submissions.
- A highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role.
About Us:
We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Our mission is to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.
What We Offer:
- A competitive salaries and benefits package.
- An inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
- Excellent career progression opportunities and work-life balance initiatives.
Contact Information:
Please submit your resume and cover letter to [insert contact information].
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