- Provide strategic technical direction for manufacturing and key engineering and technology standards. Develop processes to maintain and improve manufacturing technologies. Manage troubleshooting and change management initiatives for manufacturing processes. Engage key internal stakeholders and collaborate on new technology design and implementation programs. Management responsibility for technical aspects of technology transfers (processes, documentation and expertise). Define the scope for future tech transfers for facility. Supports site selection decisions by providing analysis of technologies, manufacturing risk assessments and relevant technical costs.
RESPONSIBILITIES:
Tech transfer management
- Review transfer protocols, project plans and timelines and guide regarding solutions to execute these
- Ensure robust information exchange and coordination, alignment of goals, and understanding between sending & receiving units
- Identify project issues and provide guidance to resolve them
Manufacturing technology troubleshooting
- Provide planned and unplanned production support
- Troubleshoot process problems
- Manage process changes, including API/IPI source changes
- Apply expert functional knowledge and experience to provide optimal project solutions
Process improvement
- Manage and develop engineering implementation and execution road maps for new technology introductions
- Support continuous process and quality improvements
- Design and control optimisation projects
- Execute technical feasibility trials for process improvement
- Drive technical discussions and decisions based on cost, operability, schedule and technical suitability
- Develop and promote process technologies, recommend strategy, best practice methodologies, and cost models
Risk management
- Assess and mitigate risks associated with manufacturing process changes and troubleshooting to achieve target improvements (such as yield improvements)
Unit management
- Provide technical and operational input during drafting of unit strategy and operational objectives
- Guide operational planning and advise on prioritisation of activities
- Provide input into budgets and resource requirements for unit
- Request and allocate assets and resources for the fulfilment of work objectives and monitor their use
- Provide unit staff with day-to-day direction and tasks
- Keep abreast of GMP requirements and technological developments
- Support project teams to execute tech transfer projects
Background/experience
- 5 years in a pharmaceutical manufacturing environment
- 10 years’ experience of manufacturing processes relating to Oral Solid Dose or Steriles manufacturing
- Bachelor’s degree in Pharmacy, Science, Engineering or similar
- Masters or PhD preferred
Specific job skills
- Excellent project management capability
- Thorough knowledge of Pharmaceutical technical issues, manufacturing processes and operations environment, including a detailed knowledge of validation, regulatory affairs, R&D, and new product transfer
- Demonstrated project management and technical leadership capability
Competencies
- Interrogating Information
- Making Decisions
- Taking Action
- Managing Performance
- Planning and Organising
- Creating Clarity
Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CVs online on or before the specified date. Preference will be given to applicants from designated groups, through a fair recruitment and selection process, in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate.
Only short-listed candidates will be contacted, thus if you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.
Internal Applicants must inform their direct line managers of their application. Applications must be completed using an Aspen email address.