SEDA Talent
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 and 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 and ROW in relation to industry best practice
- Provide technical input and evaluation for the establishment of specifications for new products
- Identify and implement continuous improvements within the pharmaceutical development department
- · Ensure all equipment is adequately maintained and to carry out qualification, cleaning and calibration of equipment as required.
- Ensure compliance with EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations
Essential Criteria
- Degree in a chemistry, analytical or pharmacy related discipline
- Relevant experience in a pharmaceutical development role.
- Extensive experience in the development and validation of methods for APIs and excipients in finished products using a wide range of techniques UPLC, GC, size exclusion chromatography as well as wet chemistry
- Expertise in dissolution method development/application.
- Experience in the field of Reverse Engineering
This role comes with a comprehensive rewards package, for more details please apply directly below or Call the Team at SEDA Talent today on 02896016225
