Address
Form of workProfile:
Functioning within the Operations Directorate in the UK and Europe, this role directs the design and development of processes, instruments and equipment from the laboratory through Manufacturing processes. Furthermore, this role will be responsible for identification, deployment and governance of clinical information technologies needed to support product development processes as well as directing and/or supporting technology initiatives and strategic vendor interactions. Manage equipment acquisition/validation, process development/validation and activities associated with R&D plant.
This role ensures that technology solutions meet the business requirements and fit within the overall systems architecture landscape. This role will work closely with business leaders, end user community, UK partners, vendors and service providers to ensure delivery of technology solutions that support the business strategy and operations. While this role does not have direct reports, it does have responsibility for leading cross-functional project teams and overseeing contractors.
Main Duties:
IT Logistics Development Duties:
1. Analyse, document, and optimize business processes and ensure fit with the existing and/or proposed solutions
2. Identify solutions that meet the requirements from the business
3. Collaborate with our client's functional leads in understanding available solutions already deployed that can be leveraged to meet a business need
4. Lead creation of business case for governance review
5. Develop appropriate project plans including timeline, resource plan, riskplan, stakeholder plan, communications plan, financial plans and business case
6. Ensure stakeholder alignment for these plans
7. Define and create project teams, including vendors and contingent workers as needed
8. Manage plan, holding appropriate stakeholders accountable for the irrespective deliverables
9. Sign off on functional solution by validating use cases, conceptual data design, screen design, supplementary requirements etc.
10. Partner with Compliance and Validation resources as needed to drive change control and system validation activities
11. Ensure delivery of projects acting as single point of contact
12. Manage the plan to deliver on-time, on-scope, and on-budget
13. Maintain stakeholder alignment throughout the project
14. Facilitate appropriate forums to manage project dependencies and integrations
15. Rapidly address issues and facilitates to successful resolution
16. Effectively communicate project status via defined process and tools
17. Effectively transition project into steady state working with the IS Operations Lead
18. Build and maintain good working relationships with the business leads and the user base
Engineering Logistics Setup
1. Oversee schedules, supplies, materials, equipment and manpower requirements in the pilot plant, and recommend programs to maximize project success, improve productivity, quality and efficiency of the R&D plant operations. 2. Provide technical leadership in the areas of process development, process validation and equipment validation with a focus on solid oral dosage forms
3. Provide functional leadership for all technology transfer related projects to assure timely scale-up and launch of new products.
4. Set up and maintain tracking system for each product defining critical process parameters
5. Responsible for writing technical summaries and process development/validation reports, author/review/approve compliant documentations (SOPs, manufacturing batch records and validation protocols)
6. Prepares, reviews and approve sections of Technical submissions when required
7. Develops and implements equipment installation/operation/performance qualifications activities in the pilot plant
8. Ensures budgets and schedules meet corporate requirements
9. Assesses utilization resources and identifies when, and where additional resources may be needed
10. Ensure staff members are appropriately trained and training records are maintained at current required levels
