R&D Section Manager - Microbiology/ Pharmaceutical Development
Salary: Competitive, plus additional benefits
Our Client, a global Diagnostics/ Medical Devices company are looking to appoint and experienced R&D Senior/Section Manager; who will manage the AST and Pharmaceutical Development side.
The successful Candidate will be rewarded with a competitive salary, plus the chance to work as part of a growing company - with a state of the art R&D facility.
- To manage the delivery of projects from the AST & Pharmaceutical development teams to meet Group-wide commercial, technical and regulatory requirements.
- To manage the 'day to day' on the Pharmaceutical and AST side.
- To work closely with other Leaders to identify product development or improvement opportunities.
- To achieve recognition of new products through publication and presentation of external evaluations
- Will be responsible for departmental budget; allocation, preservation and planning.
- To be responsible for the on-time delivery of relevant projects referred from, particularly in respect of end product form, function and cost.
- To keep abreast of the latest technical developments and regulatory requirements (industry reading, networking events and technical modifications).
- To work with the Sales & Marketing Director, Marketing personnel, potential customers and end users at a detail level with regards to the market acceptability of new product concepts including their presentation and packaging.
- To work with Manufacturing, Marketing and Product Development teams to enable sign off of the Design Cost Benefit Analyses with the Sales and Marketing Director.
- Ensuring design cost and timescale is accurately estimated so that full and complete product specifications are agreed and market potential is defined prior to commencement of development.
- To work with other companies within the Clients' Group to gain a detailed understanding of country / region specific requirements to ensure that product development meets the needs of the Group.
- To set up and cost-effectively manage the external evaluation of newly developed products including review of evaluation findings, resolution of out of specification and discrepant results, preparation of final reports and recommendations for further action.
- Ensuring governance and coherence within the QMS by ensuring that all relevant current and planned regulatory and quality system requirements are complied with.
- To work closely with the QC and QA departments to investigate and advise on the resolution of quality-related technical issues.
- Be an active member of the Innovation Team to suggest and offer advice on new product ideas.
- Control the external evaluation of fully finished new products to produce, where appropriate, published papers and/or posters from external opinion leaders
- Providing a high standard of technical service including, where appropriate the provision of practical specialist technical advice. This will include actively mentoring and training staff which is a key part of the role.
- Participating in departmental meetings to report progress of projects, and evaluations and discuss and implement resolution of technical problems using formal problem solving techniques. Provide technical training including oral presentations on courses for sales and marketing, and laboratory personnel.
- Identify opportunities to register/protect new Intellectual Property/know how, and to work with the Molecular Development Manager, Director responsible for R&D and our IP lawyers to secure cost effective protection.
- Identify opportunities to raise grant funding for Client Developments.
- Staff training is adequate in relation to the job to be undertaken and the skills/experience of the person undertaking the role, performance reviews are carried out and that records are kept.
- Staff are adequately protected in their working environment that they use safety equipment and clothing specified that they understand the need for protecting themselves against laboratory hazards and take all necessary precautions to avoid such hazards.
- Staff sickness and absence is minimised and in any event, should be no more than 1.8 per cent of total working hours.
- Will hold a PhD in Clinical Microbiology, Biomedical Sciences or Biochemistry or have significant R&D Microbiology Management experience to counter this.
- Five-year's direct management of multi-functional development teams
- Will ideally have worked in the NHS or equivalent health service in a diagnostic laboratory but MUST have experience working in a product development and delivery environment
- Will have ideally have working knowledge of GMP, iso 13485 and GLP regulations
- Strong management and leadership skills; with experience in budget allocation - having a commercial head coupled with the technical/ extended Microbiology expertise.