Head of CMC Development

We are currently looking to recruit a Head of CMC Development to join a leading Pharmaceutical company based in the North West.

Job Purpose Summary:

This role will be to manage all development projects, internal or client driven with direct responsibility for setting and delivering against, budgets and timelines needed to generate quality submission data.

Key Responsibilities and Duties:

Set budgets and timelines for development activity.
Manage, mentor and develop analyst team to delivering against, budgets and timelines for development activity.
Engage in resource planning and associated costs prior to commencing new projects.
Research and determine work plan for development process of each project.
Ensure full compliance with current expectations of regulatory bodies.
Ensure full communication of project tasks and timelines.
Provide technical support to analytical, operational and client teams throughout the project life.
Provide technical support to the regulatory affairs group to assist in regulatory fillings.
Conduct regular project team meeting to ensure that the project is on track and provide a forum for debate and discussion of any issues missed and look to proactively manage to re-engage with project timelines.
Provide monthly written updates for submission to the board and or development steering committee.
Undertake own career development to ensure the continuing growth of development activities within the business.
Conduct all work in a GMP environment and adhere to all established procedures.
Where Necessary generate GMP documentation inclusive of SOP's, technical reports, process development reports etc.
Look to develop strategies to reduce costs of development and speed up time to submission.

Accountabilities

Responsible for drafting and delivering against development project plans.
Responsible for delivering development projects in line with business objectives.
Responsible for adherence to budget of development activities and ways of reducing submission time.
Responsible for managing internal development projects.
Responsible for ensuring that any b reaches in H&S, GLP and any other company. rules are reported immediately and managed.
Responsible for highlighting any cost implications associated with projects.



Skills, Experience and Education required or desirable

Experience within a Pharma product development role.
Experience in project planning.
Experience within a Generic Development or contract development.
Ability to build team work and open channel of communication.
Business focused, inclusive of behaviour and attitude.
Ability to influence change to allow the business to remain relevant.
Ability to create ideas, understand the need for change and embrace it.
Good communication skills, and willingness to participate in team discussions.
Experience in a number of different dosage forms.

Key Performance Indicators

On budget on time delivery of each project
Development of laboratory staff
Timely submission of development plans
Adherence to development project plans
Right first time - Quality and Performance- Zero defects.
Health and Safety performance - accidents and lost time.
Inspection ready at all times.

Hyper Recruitment Solutions (HRS) is a niche and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.