- Defining integrated solutions & plans in the analytical field (e.g. release & testing strategy) for designated chemical development product(s), starting from Phase I to first commercial approval;- Implementing those solutions & plans through projects leadership;Collaborating with Analytical Product Owner (APO) to support lifecycle management;- Taking accountability of key analytical deliverables of the corresponding drug substances and drug products (e.g. methods, specifications, stability and regulatory submissions) to support the Pharma Sciences and Technical Operations network and ensure supply continuity for patients;- Anticipating needs in the analytical field to mitigate risks and create competitive advantages for your product(s).
EducationMaster's Degree (required) with PhD in Analytical Sciences (preferred);
Experience- Expert in the analytical testing field with a strong experience on CMC development strategy for NCE (starting from Phase I to commercial readiness) (minimum 5 years' experience);- Project leadership skills including planning, monitoring, issue resolution, risk mitigation, decision making and reporting;- Experience in GMP, Regulatory Affairs and Quality applied to analytical;Ability to lead and influence people in a matrix environment;- Change management skills with a strong sense of accountability & responsibility
- Agile mind that enjoys being analytical- Connect with people to build a strong network, both internally and externally;- Be proactive to eensure that relevant analytical activities are initiated at the right time to meet timelines deliverables;- Drive the decision making process in a matrix environment;- Work in autonomy with a problem solving & pragmatic mindset;- Continuous improvement/problem solving.
To apply for the position of Analytical Project Leader role send a CV / Application to email@example.com or call Mathilde on +44(0) 161 804 4359.