Industrial Affairs Specialist

Come and Save Lives with Us!

The Company is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases.  We have over 400 employees in 16 countries.

Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority    
• We act with integrity and accountability 
• We work together as one team  
• We look for better ways forward

Broad Overview

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.

As an Industrial Affairs Specialist, some of your responsibilities will include:

a)         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.

b)         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).

c)         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.

d)         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.

e)         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.

f)          General

• Work within the Company procedures and processes.
• Travel to and spend time as required at suppliers, contract manufacturers or other potential partner sites.
• Ensure that all interactions and engagements are carried out in a professional, efficient, courteous manner and that all work is accomplished with quality and in accordance with Company values.
• Carry out other reasonable tasks as required by the Line Manager.

To be successful in this role, you should demonstrate:

• 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, trouble-shooting 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.
• Ability to speak and write fluent French is desirable

Company Benefits:

• 25 annual leave days plus bank holidays and 3 annual company closure days (to be taken between Christmas and New year)
• Competitive Pension Scheme 
• Private Medical Insurance
• Discretionary Bonus Plan
• Paid Maternity and Paternity Leave
• Academic Study Assistance
• Eyecare vouchers
• Employee Assistance Programme

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.