IT Project manager – Bio Tech

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, 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.

Qualifications and Person Specification:

1. MA or PhD in Life Sciences, IT or Engineering.
2. Experience with technology evaluation, deployment and project management required.
3. 10 + years management experience in bio–tech or Pharmaceutical industry, preferably with some years experience in Technical Development as well as managing Implementation of R&D Projects.
4. 5+ years of professional IT experience running high performing environments in multiple technical and business domains
5. Excellent written and verbal communication skills
6. Ability to work collaboratively in realisation of overall project objectives; successful partnering with internal and external stakeholders; clearly define expectations, roles and responsibilities and facilitate cross–functional stakeholders in support of project deliverable
7. Demonstrated project management skills – able to effectively plan and manage complex projects; quickly identifies real or potential issues, seek practical solutions and escalate appropriately
8. IT and business knowledge to manage IT delivery processes end–to–end
9. Ability to bridge functional requirements with IT solution components
10. Demonstrated facilitation skills
11. Demonstrated business requirements gathering skills
12. Good understanding of system validation process
13. Good understanding of change control process
14. Project Management Professional certification a plus
15. Experience in the pharmaceutical/bio–tech industry, specifically in the Research, Clinical, Biometrics and Quality functional areas
16. Demonstrate outstanding business and operational leadership capabilities, including the realisation of operational excellence programs to improve reliability and agility in a highly dynamic environment.
17. Excellent communication and interpersonal skills with success in influencing others in cross–functional areas.
18. Effective cross–functional collaboration skills with proven ability to build and maintain strong and sustainable relationships with internal and external customers, partners and stakeholders
19. Demonstrated ability to lead within a matrix organisation and to manage multiple interfaces and stakeholders.
20. Technical Experience in at least one of the following: Parenteral or Solid Drug Product Manufacturing/Development,
Biotechnology or Chemical production/development, Analytical Development or Quality Control
21. Excellent people leadership and management: hire, train and develop outstanding talent and ensure robust succession and development planning.
22. Innovative, forward–thinking, scalable and sustainable vision, strategy, objectives and plans for the assigned network
23. Ability to set and achieve aggressive milestones through cross–functional teams

Main Duties:

IT Logistics Development Duties:

1. Analyse, document, and optimise 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 IS 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 time–line, resource plan, risk plan, 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 their respective 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 integration
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

Engineering Logistics Setup

1. Oversee schedules, supplies, materials, equipment and manpower requirements in the pilot plant, and recommend programs to maximise 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 specific 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 utilisation 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
11. Influence product formulation/process to optimise use of facility equipment
12. Provides regular performance feedback, development and coaching to direct reports
13. Provides input into strategic and operational plans and directions, ensuring the plan and deliverables are aligned and understood in order to achieve performance expectations and decided metrics.
14. Design – Generates creative solutions; Demonstrates attention to detail.
15. Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyses information skillfully; Develops alternative solutions; Works well in group problem solving situations.
16. Project Management – Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities