JOB DESCRIPTION
Job title: Technical Project Manager
Reporting to: Director, Scientific Affairs
Department: Scientific Affairs
CNX Therapeutics is a European pharmaceutical company dedicated to improving the lives of patients through the supply of essential medicines.
We license and distribute a portfolio of medicines for CNS, critical care and other conditions, both directly and through strategic partnerships, in over 60 countries worldwide.
Our vision is to become a recognised partner of choice through our commercial excellence, patient focus and presence across Europe.
We want to be Pioneers! We may be small, but we’ve got some big goals. That’s why, at CNX, ESG (Environmental, Social, and Governance) isn’t just a fancy acronym; it’s a roadmap to our future success. Why, you ask? Well, it’s because we want the work we do to have a positive impact, on ourselves, on each other, on the world we live in and on the patients we serve.
And guess what? It’s on all of us to do this. So, whether you’re crunching numbers, selling products, moving those products around, maintaining our high ethical standards, or brainstorming new ideas, remember that every small action counts. CNX will do its bit for you through our inclusive and family-friendly benefits and ways of working, supporting your professional and personal growth, so you are empowered to pay it forward every day.
The Role
This role will be responsible for the coordination and delivery of technical projects, predominantly in support of Scientific Affairs, Strategic Projects and Corporate Development. The role requires the proven ability to work across internal functions and to operate effectively with Contract Manufacturing Organizations (CMOs).
The incumbent will have a strong analytical, formulation or process background, excellent communication skills, and the ability to work collaboratively with various teams.
Core Tasks and Responsibilities
Live the CNX Values. Maintain high standards of ethics, and support the company in its efforts to have a pioneering approach to environmental, social and governance (ESG).
- To follow, promote and enforce relevant SOPs, Work Practices, and Company policies and procedures.
- Responsible for the coordination, scoping and costing of Technology Transfer activities for API and finished products.
- Responsible for the planning and execution of technical projects using a set of agreed “project tools”. Including preparation of project plans and hands on participation in the practical delivery of the plan and project deliverables.
- To be responsible for the technical ownership / stewardship of Commercial Products manufactured API and finished products processes (manufacturing, quality control, packaging and release) with respect to the planning, review and approval (via change control) and implementation of changes in conjunction with CMOs. To be the point of contact for technical investigations (deviations) and remediation (CAPAs).
- To work cross functionally within CNX Therapeutics Ltd. (predominantly Corporate Development and Strategic Projects) to identify, evaluate and manage continuous improvement projects (process enhancements which provide a measurable improvement in Quality or productivity).
- To be involved in due diligence processes as required and as lead by the team by providing technical input. To support the integration of new product acquisitions into the Quality, Regulatory and Technical systems and processes.
- To be responsible for the technical evaluation of stability data and manufacturing processes using statistical process control / process capability techniques, so as to ensure data and processes are in control.
- Responsible for ensuring the Quality, Regulatory and Technical departments are aware of all current and future changes to European and ROW technical and quality legislation. To lead assessments of the impact and actions necessary to ensure that CNX Therapeutics Ltd. would be compliant with any draft legislation.
- Undertake other tasks and duties as delegated from time to time from Senior Management.
Background, Skills & Experience
- Background in pharmaceutical Technical Transfer essential, experience in manufacturing and/or R&D preferred but not essential, knowledge of analytical requirements associated with Tech Transfers and/or pharmaceutical packaging processes is useful.
- Understanding and experience of established processes of a product lifecycle; experience across all stages of Technical Transfer and in successfully delivering the transfer of pharmaceutical products, management of third party contract manufacturing vendors, experience in APIs, oral solid dose and/or sterile pharmaceutical products, packaging transfer activity experience useful but not essential.
- Skills - Remote management; technical contract review and negotiation; accountability; working to deadlines; independent worker; decision making; effective communication with cross functional teams (PV, QA, Regulatory, Supply Chain, Strategic Projects); problem solving; delivery skills; ability to influence and take holistic views across product lifecycle; identifying opportunities and risks; troubleshooting day to day issues with virtual supply chain; broad technical knowledge coupled with commercial acumen & relationship management skills; due diligence for acquisitions and subsequent integrations.
- Role will involve approx. 15-20% travel