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Associate Director, Technical Services
My client is a small integrated pharmaceutical operation. Currently the site manufactures a single commercial product. The site also provides technical support to many products in development, clinical and commercial products manufactured in CMOs.
The site is in a transition phase, whereby it will manufacture multiple commercial products, clinical supplies as well support other manufacturing operations completed externally. The QC function on site currently offers many supports in terms of stability studies, alternate release testing site for final finished product.
This role will supplement and add to the existing technical support on site.
Provide technical support for existing manufacturing processes, in addition to development, commercialization, technology transfer of new processes into the operations/manufacturing environment
Reporting into the head of Operations the role will provide scientific and technical leadership for drug product manufacturing on site as well as supporting external sites on an as needed basis.
This position is responsible for providing strong scientific leadership for all aspects of technology transfer, process scale-up, process monitoring, and process troubleshooting to, drug product and finished product manufacturing activities on site (and as needed offsite). This responsibility includes all process validation activities.
Manufacturing process Scale up development including life cycle management projects
Qualify and perform experiments in small scale models designed to further understand and improve the manufacturing process.
Master documentation for standard batch. Establish & update technical documentation such as:
- Process Flow Diagrams
- Control Plans
- Support operations with continuous improvements
- Continuous Process Validation (CPV) Owns the process knowledge of the assigned product(s) throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters
- New technology & Equipment introduction responsible for performing technical feasibility trials related to process improvement and implementation of new manufacturing technologies
- Trouble shooting process and equipment issue technical input to significant issues/ deviations etc
- Support continuous improvement in the manufacturing and development of products.
- Liaise with global Process Development & Manufacturing Sciences group to facilitate transfer of technical knowledge.
- Keep up to date with regulatory requirements
- Liaise with Quality (APQR etc) to support the Annual Product Quality Report (PQR) by completing Data analysis, process monitoring & evaluation, etc.
- Owner of technical services plans/ methods/ standards (Operations team will be responsible for execution to these standards/processes)
- Maintenance Management
- Calibration Management
- Clean utility systems & strategies
- P&ID maintenance
- Provide support as appropriate to New Product and Technology Introduction team
- Technical lead on interface with regulatory inspections
Required Knowledge, Skills, and Abilities
- Minimum 8 years industry experience including manufacturing, process support, process troubleshooting, experience of in house and external manufacturing environments, design of experiments, process validation writing and execution.
- Min 5 years’ experience in lead SME role in regulatory audits
- Strong Organisational skills – in particular for knowledge management
- Training and experience in problem solving skills e.g. 5 whys, fishbone diagram.
- Project management an advantage
- High level of competence with MS Word/Excel/Power point
- Strong communicator
- Broad knowledge in pharma technologies and dosage forms (small molecule Drug Product development and manufacturing, Low Bioburden manufacturing and complex liposomal product are all beneficial)
- Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority.
- Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems. An ability to think strategically and be a ‘go-to’ expert across the business in area of expertise.
- Recognize areas for improvement, and use initiative to implement change programs in support of progress.
- Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
- Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.
- Ability to generate documentation which is of a high standard.
- Posses good organizational skills and attention to detail.
- Posses good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines.
Required/Preferred Education and Licenses
- Relevant Science /Engineering
- MSc / PhD desirable