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Director, Pharma Regulatory Services - United Kingdom - Glasgows
Description
Sai Life Sciences Ltd - Analytical DirectorAnalytical Chemistry Director / Head of Department
Permanent
ASAP
Sai Life Sciences is a leading global Contract Research & Development and Manufacturing Organisation (CDMO) that provides integrated drug substance services to the biotech and pharmaceutical industries.
With expanded process development labs in Manchester, UK & Hyderabad, India, and increased commercial manufacturing capacity in Bidar, India, Sai is working with 17 of the top 20 pharma companies globally, as well as many leading smaller biotechs.
We work with our clients to accelerate the discovery, development and manufacture of complex small molecules for a healthier tomorrow.
With more than 3000 staff globally and ambitious growth plans, our vision is to support our global innovator partners to bring 25 new medicines to life by 2025.
In 2019 the company began an organisation-wide initiative to significantly expand and upgrade its R&D and manufacturing facilities, deepen scientific & technological capabilities, strengthen automation and data systems, and above all raise the bar for safety, quality and customer focus.
Part of this investment in 2020 were the new state of the art laboratories in our centre of excellence for process chemistry and analytical development at the Alderley Park Science Park, situated on the outskirts of Manchester.
Non-GMP manufacture of kg quantities of intermediates and APIs is currently possible within our bespoke Scale-up laboratory facility and a new GMP Kilo-lab facility was brought online in 2023 capable of kg quantities of GMP API suitable for early phase clinical studies.
Developed processes are frequently transferred to Sai's manufacturing sites in India for further scale-up when required.You will get to work closely with some of the most innovative biotech and pharma companies on their most important programs.
Occasional travel, domestic and international to India may be required.We are looking for an experienced Scientific and Line Leader who is seeking a new challenge.
The candidate would lead a department of highly skilled analytical chemists and would also be expected to generate and review technical proposals for potential new projects
Have an overview of all the development projects within the Analytical organization and guide the resource prioritization
Higher or bachelor's degree in Analytical Chemistry or related scientific discipline with several years' relevant experience in an Analytical Chemistry laboratory within the pharmaceutical industry.
In depth understanding of working to cGMP and analysis and release of material for clinical supplyStrong scientific track record with both project and line leadership experience.
In depth understanding of regulatory requirements for the development and validation of methods for pharmaceuticals, including the separation of impurities and degradation products in APIs
The successful candidate will also have experience of line management and enabling the personal development of a team of scientists.
To be part of the Sai Manchester Site Leadership Team – and contribute to the management of the Site, working with the Head of R&D and head of Site and other Technical heads of department.
Line management and personal development responsibility for direct reports which would include team members and first line managersResponsible for the scientific output of the analytical chemistry department and their contribution to customer projects.
Work within multi-functional project teams operating to tight deadlines, working collaboratively with other departments.
Lead the analytical aspects of projects both at Alderley and with analysts in India.
Guide the resource planning and help prioritize analytical work to meet project timelines.
Able to work effectively to GMP Quality Standards.
Good project management and supervisory skills.
A competitive Salary and Benefits package including company pension, health and life insurance, 28 days holiday per year and enhanced family leave.
Work in a state-of-the-art facility on one of the country's leading Biotech & Life Science Parks.Flexible working hours and conditions to suit the right candidate.
As an Equal Opportunities employer, we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.
Please note that Sai Life Sciences Ltd is unable to sponsor the visas for any candidates for the above role.
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