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Form of work
SalaryOur Client develops and distributes innovative, high-value specialty pharmaceutical products. They are now seeking a Technical Specialist - Pharmaceutical QC & Manufacturing. This position is a full-time permanent role which will be office based in Surrey with blended (hybrid) working arrangements currently in place and expected to continue on a non-contractual basis in future.
Job Purpose
- Take day-to-day responsibility for managing Tech Transfers, trouble-shooting activities, and project management to secure existing manufacturing processes and active ingredients supplies and support new product development within the group.
- Products are both unlicensed or licensed and intended to be distributed both within the UK and internationally.
- Ensuring that the projects are being run according to agreed timelines and costs, and that robust and appropriate decisions are made at each stage of the project.
- As required, liaise with contract manufacturers, development facilities to assist in identifying optimum solutions to technical problems, plan and implement the solution with the selected facilities, and coordinate activities, flow of information and completion of Quality Management System documentation with office-based colleagues
Key Areas of Responsibility
Manage existing and new projects development
- Participate to CMO/CDMOs screening for selection for Tech Transfer or new development. Participate in the RFP process by compiling required information.
- Collect and review process validation and analytical method validation data highlighting any out of specification/trend results.
- Support generation of stability, process validation and analytical method validation protocols.
- Manage and monitor the progress of validation activities (analytical and Manufacturing process) and stability studies, highlighting any out of specification/trend results.
- Review batch documentation updates for existing commercial products and assess impact on process robustness or product quality, highlighting significant variances.
- Generate change controls for new product introductions and changes to existing products. Work in collaboration with internal stakeholders to identify and design technically viable and pragmatic product development opportunities (both unlicensed and licensed products).
- Identify and recommend the best contract development and Manufacturing partner for each project.
- Plan and cost out projects and ensure that realistic and credible project plans are constructed and maintained as live working tools.
- Identify the appropriate resources (financial, expertise, equipment) required for each project.
- Ensure that projects are conducted in a transparent manner and that legitimate stakeholders receive updates and communications in a timely manner.
Develop the technical and clinical data of selected product to CTD standard to support MAA
- Identify the weaknesses and gaps in the product development of selected products and, in conjunction with external suppliers, develop plans and costings to generate data to achieve robust common technical documents (CTDs).
Troubleshoot manufacturing issues
- Work with contract manufacturers and colleagues to identify and implement robust and optimised solutions to product supply related problems as they arise (process or analytical related). This will include sourcing active ingredients from alternative suppliers and managing technical transfer of products to a new site of manufacture.
- Identify new sources of materials and new sites of manufacture to agreed timelines (as required) and costs in coordination with other departments (Quality, Supply..)
- Assist in the investigation of out of specification/trend results
- Review batch documentation updates for existing commercial products and assess impact.
Complete Company documentation (including Quality & Financial) in a timely and accurate manner
- Ensure primary documentation at the external partner companies is prepared and signed off in advance of a decision being implemented.
- Accurately document agreed activities with a clear audit trail.
- Complete of QMS and financial management documentation in a timely manner.
- Prepare and send purchase orders in advance of work being undertaken by contract manufacturers and suppliers.
Clear communication to internal SPL stakeholders
- Report periodically on project progress, advising stakeholders of challenges in a timely manner.
- Ensure all documentation is generated in compliance with internal procedures, SOPs, in compliance with the required quality and regulatory guidance.
- Ensure that primary documentation at the external partner companies is generated on time according to planning.
- Monitor, record and attribute costs associated with technical projects.
- Document the activities according to the current project process (trackers, classification of files etc.).
Qualifications / Experience
- BSc or equivalent science-based degree
- Prior experience of working in a Pharmaceutical production or development environment, to include working with staff on issues arising within a production environment.
- Familiar with the concepts of GxP systems and other pharmaceutical terms and acronyms.
- Experience of managing Tech transfers, troubleshooting and product development of product change projects including process, analytical, planning, documentation, cost control and communication.
- Experience or ability to fill eCTD module 3.
- Ability to establish and maintain effective working relationships with internal and external stakeholders.
- Strong written and verbal communication skills, including the ability to put forward a coherent and compelling case, taking the needs of other stakeholders into consideration.
In return our client is offering a competitive package for the successful Candidate including a basic salary of up to £59,000 per annum (negotiable dependent on experience) plus benefits.
Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.
