JOB PURPOSE
To manage the integration of technical projects across the Aspen Group with high focus on sterile products.
Apply expert functional knowledge and experience with sterile products, to provide optimal project delivery
Responsible for taking cost saving, supply sustainability, technical transfer and regulator initiated projects and converting them into relevant product supply, through designing, problem solving and executing technically sound delivery solutions
Overseeing and managing all aspects of project scope, timelines, cost, resolving technical related issues ensuring successful product transfer.
KEY PERFORMANCE AREAS
Manage the technical transfer process, according to the relevant department procedures and SOPs, from initiation to completion

Facilitate processes which include feasibility, planning scoping and initiation of new projects
Manage delivery of site technical project plans and generate overall timeline from project initiation to first supply for review by sponsors and stakeholders
Design and fix processing of products to improve the product quality

Management of overall project costs and budget

Direct site for technically challenging issues and generating business case models to implement new or enhance existing processes.
Management of technical service providers, challenging the costs and benchmarking quotes.
Manage project budget through the Project Budget Management Process, including decisions on approval of forecasted expenditure and assessing impact of scope and timeline changes on yearly and overall Project Budget

Collaborate’ communicate with all stakeholders to ensure successful implementation of Project Metrics

Manage Project and technical meetings including Kick off, close out, weekly progress and ad hoc technical meetings with Ownership of agendas, minutes ’ action item repository
Provide monthly status updates for projects to facilitate the monthly dashboard reporting, quarterly Board reports and risk registers
Assist Group or site procurement by providing information required to source quotes for components / raw materials or alternate material sources
Manage technical queries/issues between sending and receiving sites and act as Product SME when in house expertise is not available
Troubleshoot process problems, Support sites with Root cause investigations, writing of reports and closing CAPA’s
Manage project risks and escalate significant changes in timelines to manager
General project communications keeping stakeholders informed and directing daily workflow across sites
Provide Technical inputs into Site and Project Portfolio Steercom meetings

Provide support to Regulatory teams to ensure submission timelines, Requests For Information (RFI’s) and technical related queries are actioned within the stipulatedtimelines

Manage technical queries from supply and Regulatory hubs and support strategies concerning submission. Provide review of compiled dossier sections
Manage responses and closure of RFI’s from regulators by directing and coordinating site responses and authoring justifications where relevant.

Deliver Group KPI’s though successful completion of critical milestones associated with project plans and meeting scheduled implementation dates within defined budget

Apply expert functional knowledge and experience to provide optimal project delivery
Risk mitigations to prevent impacts on timeline and cost

Sterile Subject Matter Expert (SME)

Aseptic and terminal sterilized products, (solutions, emulsions, lyophilized products,
Primary packaging components (Vials, ampoules, stoppers, caps, PFS, Blow fill seal products, Single dose ’ Multi-dose)
Filters ’ Filter validations,
Autoclave cycles;
Single use technology;
Extractible and leachable studies / Antimicrobial effectiveness testing / Elemental impurities / Delamination studies
Visual inspection ’ leak detection;
Provide internal training on key aspects related to sterile products pharmaceutical manufacturing
Guiding and Mentoring of the junior members of the projects team

Ad Hoc / Specific Activities

Keep abreast of latest technical developments and GMP requirements
Provide Support / assistance to other Project managers in the Group Operations Technical projects and Group Operations Projects Team as and when required

Requirements
JOB REQUIREMENTS
EDUCATIONAL QUALIFICATIONS ’ EXPERIENCE

Degree in Science, Process Engineering or Biochemical Engineering
University qualification
5 – 10 years’ experience in the pharmaceutical, biological or biochemical environment dealing with sterile product processing

SPECIFIC EXPERIENCE, KNOWLEDGE AND REGISTRATIONS

5 years relevant project management experience

Working knowledge of pharmaceutical standards/ compliance
High technical expertise in sterile products: process, sterilisation, materials and primary packing components

WORK-SPECIFIC SKILLS ’ EXPOSURE

Pharmaceutical industry work experience in a manufacturing facility
Pharmaceutical supply chain, regulatory, laboratory and Quality knowledge preferable
Core knowledge of pharmaceutical manufacturing, GMP and Quality (Deviation classification and justification) and technical transfer (ISPE)
Report writing
Budget management
Sound Knowledge of IT, excel, word, MS projects, Power point, Dashboards

SKILLS AND ATTRIBUTES

Ability to work in an international and dynamic environment
Planning ’ Organising
Accuracy ’ attention to detail
Disciplined and focused
Effective Time Management
Problem solving ’ Decision making
Information seeking ’ sense of urgency
Analytical ’ Analysing skills
Interpersonal skills
Clear ’ Effective communication skills (Internal ’ External)
Translate and direct project strategy, make decisions based on sound principle
Assertive
Initiative
High level of integrity, ethical values ’ confidentiality
Self-motivated, Performance driven ’ efficient
Flexibility to work outside standard office hours (time zones)
Flexibility to travel locally ’ Internationally as required
Budget skills / knowledge

KNOWLEDGE

Financial Principles
Principles governing regulatory and quality requirements such as GMP, ICH, SUPAC guidelines on stability, validation of processes, equipment classification
Regulatory market requirements – USFDA, EU, TGA, WHO, SAAPRA, ANVISA, NMPA (China)
Pharmaceutical ’ Technical Industry Knowledge
Project Management basics and tools

ASPEN COMPETENCIES
Business

Multi-tasking
Focused
Leadership
Teamwork

People

Embraces change
Capacity for ’ Resistance to stress
Meeting facilitation

Self

Contributes special expertise
High Standards
Personal responsibility
Self-assurance