Technical Lead - Reverse Engineering
SEDA Talent have partnered with a pharmaceutical manufacturer, to recruit for a Technical Lead to join their team in Co. Down. This company leads the field in veterinary products, their portfolio of products is distributed across the world, and they have a total commitment to innovation, quality and delivering value to their customers.
The Technical Lead will provide technical support to the pharmaceutical development team in support to the design, execution and reporting of reverse engineering studies for new products and will work with in the team to develop a wide range of Pharmaceutical Dosage Forms
Responsibilities
· Lead the design and execution of reverse engineering studies to support the development process for pharmaceutical equivalence projects
· Develop and validate analytical methods, where required, to support reverse engineering studies in accordance with the relevant guidelines
· Lead and support the development and validation of dissolution studies within the department.
· Provide technical support to the pharmaceutical development team to aid in troubleshooting of analytical methods.
· Compile and review protocols and reports in line with both industry standard and company procedures.
· Support the preparation of documentation and responses to regulatory submissions and queries
· Maintain an awareness of current guidelines in UK/Ireland, EU, US...