- Farnham, Surrey
- £30-35k + bonus
- dh 23
- 01267 610 902
Process Engineer £30-35k + bonus
Our Pharmaceutical Client is a growing international specialist healthcare company. Their mission is to bring to market medical products that meet the needs of specialist healthcare physicians and their patients. We have an exciting opportunity for a Process Engineer.
The role will be reporting to the Senior CMC/TPM Manager – Interventional Medicine; and be responsible for the management of CMC and development activities supporting their products, ensuring security of supply to support clinical and commercial products as required.
- Ensure security of supply to support clinical and commercial requirements across their portfolio, in line with all relevant guidelines (GMP, GLP, GCP), from the third-party manufacturing network.
- Support and manage technical interaction with TPM and Innovation to support New Product Introduction, technical transfers, process validations, on-going clinical and commercial manufacture.
- Provide technical and CMC support on contract negotiation and strategic planning for the product supply chain.
- Work with Legal, Quality and management to negotiate and implement new contracts (Quality Agreements, Supply Agreements (commercial and development) to add value to their portfolio.
- Provide key input into S&OP process for all relevant products, ensuring accurate supply scenarios are presented as required and provide integration of external and internal planning.
- Provide specialized technical CMC input to project teams including defining and implementing product development/ Manufacture plans to ensure optimum target product profile is met and maximizing value.
- Support regulatory filing’s (IND, IMPD, NDA, BLA, PAS, CBE30, BPDR’s), including preparing and reviewing CMC sections as required.
- Support the preparation of the CMC/TPM budget and ensure adherence.
- Provide key technical input into the development & commercialisation strategy of the Client’s portfolio of products.
- Drive continuous improvement projects within the TPM network, providing technical input whilst ensuring compliance to the QMS.
- Support intra site projects.
- Provide technical support and project oversight for projects / programmes at critical partners within the TPM network.
- Management of technical projects in support of product life cycle strategy at third part contractors
- Undertake regular FMEA and CPP review, maintain risk registers and process schematics
- Support, Develop, maintain and monitor KPI’s CMC project activities
- Provide monthly report against performance and objectives
- Support internal manufacturing network when required
- Ensure projects are delivered on time, in-line with all relevant guidelines, to budget, and in line with business needs
- Complete additional tasks considered necessary to meet business and customer requirements as indicated by the Line Manager.
- To adhere to polices on health, safety and workplace policies.
- Accountable to – Senior CMC/TPM Manager
- Internal – Works closely with CMC, Operations, Innovations, Commercial, Clinical Development, Regulatory, QA, BD, Legal, patents,
- External – Strong interaction with external CMO’s/CRO’s and other third-party suppliers
Education and Experience
- Bachelor’s Degree with a sound technical background
- 2 Years + experience in Pharmaceutical/Medical device Development and Manufacturing
- Understanding and hands–on working knowledge of cGMP, quality and regulatory requirements for clinical and commercial material
- Demonstrated ability to successfully manage small technical projects
Skills and Attributes required
- Demonstrated ability to successfully manage technical activities
- Excellent communication skills and the ability to interact cross-functionally
- Strong financial awareness
- Project planning skills – ability to construct project plans and identify critical path activities
- Ability to understand and analyse complex data and to identify critical issues; ability to identify and implement corrective actions.
- Willing to travel within EU or internationally for up to 25% of time.
To apply for this job please fill in the form below. You can also upload your CV to support your application.