Key Roles/Responsibilities
Chief Accountabilities & Responsibilities
- Daily Work:
- Responsible for project deliverables in line with agreed objectives and timelines.
- Provide technical support and advice for manufacturing activities relating to processes developed or transferred into Piramal.
- Responsibility for analytical / process conclusions reported.
- Daily leadership of small development team across multiple projects
- Mentoring of Scientists and direct line management responsibility
- Quality:
- Follow protocols and procedures
- Improve and challenge Quality systems and current procedures – strive for improvements
- Regulatory understanding and compliance
- Manufacturing Support:
- Support / guidance for first time manufacturing operations, troubleshoot scale-up
- Housekeeping / ESH:
- Ensure safety and hygiene standards are maintained
- Comply with COSHH and Risk assessments
- Training:
- Manages staff utilisation, training and development
Critical Tasks
- Managing scope and milestones (timelines)
- Managing project budgets
- Accuracy of raw data and analytical interpretations
- Client interaction / interface at front of business and new project enquiries.
- Provide technical support relating to processes developed or transferred into Piramal.
Key Result Areas & Measures
(Quantitative/KPI/Qualitative)
- Delivery of development projects on time, in budget and to agreed quality measures.
- Client interactions and new proposal / project interactions
Competencies
Critical Skills
- Protein modification and Conjugation Chemistry techniques, ADC purification
- Process robustness and optimisation studies
- Product characterisation of Final Product
- Analytical characterisation of Bioconjugates
- To provide technical expertise on bioconjugation programmes
- Data interpretation, presenting/reporting conclusions and recommendations
- Excellent communication skills
- Good working relationships with all internal colleagues, across departments, and external clients
- A proven track record of planning and delivering development work programmes
- Independent and analytical thinking
Qualifications
Essential Qualifications:-
Educated to higher degree level in Chemistry / Biochemistry discipline with at least 4 years relevant experience, or educated to degree level with at least 6 years relevant experience.
Essential Experience:-
- Experience leading scientific teams and providing technical support
- Understanding of regulatory requirements
- Understanding of GMP