Key Roles/Responsibilities
Chief Accountabilities & Responsibilities
* Daily Work:
o Responsible for project deliverables in line with agreed objectives and timelines.
o Provide technical support and advice for manufacturing activities relating to processes developed or transferred into Piramal.
o Responsibility for analytical / process conclusions reported.
o Daily leadership of small development team across multiple projects
o Mentoring of Scientists and direct line management responsibility
o Quality:
+ Follow protocols and procedures
+ Improve and challenge Quality systems and current procedures – strive for improvements
+ Regulatory understanding and compliance
* Manufacturing Support:
o Support / guidance for first time manufacturing operations, troubleshoot scale-up
* Housekeeping / ESH:
o Ensure safety and hygiene standards are maintained
o Comply with COSHH and Risk assessments
o 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
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