Head of Method Validation
Reporting to the Head of Quality Control, this role is responsible for devising and implementing the long-term vision and strategy for a dynamic and expanding method validation team, based in Slough, validating phys/chem methods and bioassays.
The incumbent will devise the technical and financial roadmaps for the department's on-going success.
With 40 members of staff (direct and indirect), you will need exceptional people management skills in order to maximize their professional and technical development. This will be key in ensuring the continuing success of the department.
The person will be responsible for ensuring flawless execution platform method evaluations, validating new methods and maintaining platform methods in line with regulatory expectations. The individual will also ensure laboratory compliance / adherence to GMP and Company Quality standards. It is expected that lean lab principles will be used to deliver testing and that a continuous improvement mindset is embedded within the organization.
- Developing and delivering the long-term vision of the Method Validation department and supporting the QC strategy and vision
- Ensure that the laboratories are compliant and host customer / regulatory audits as required
- Responsible for the scientific and financial success of the department
- Provide leadership for the development of technical and scientific capabilities to improve/maintain quality of study activities delivered to Customers
- Identify and deliver work packages in support of drug development and commercial programs
- Devise and deliver the scientific road map for the department
- Develop and implement efficient work processes across the department, e.g. Lean Lab, 6S and continuous improvement
- Control, monitor and take action on financial aspects of the department (revenue, profitability, spend and variances)
- Prioritise (with input from key stakeholders) studies and resources for on time delivery of work
- Define and maintain headcount and lab resources within 10 % of agreed targets
- Use regulatory knowledge to ensure that appropriate data is provided for IND/BLA submissions and that methods comply with guidelines
- Be fully aware of and able to further improve GMP systems as applied validating and maintaining methods through their lifecycle
- Present and represent the Department and the wider QC department / services to Customers, potential new customers, external meetings and other Company sites
- Provide coaching, mentoring and training to ensure that the team have the required skills and to ensure that team members are developed
- 15+ years industry experience in Pharma/Biopharma
- 5+ years' experience in people management
- Experience in analytical method validation
- Both small molecule and large molecule method experience considered
- Able to manage in fast-paced environments