Job Description
The Analytical Technical Lead will be responsible for collaboratively creating science-driven project plans together with DS, DP, RA, and QA line functions. Their efforts will be central to enabling CMC-team effectiveness through active prioritization, robust development strategies and supply plans, effective risk management, and ensuring appropriate resourcing.
Key Responsibilities
- Technical lead for analytical projects
- Accountable for all analytical deliverables for the assigned project portfolio
- Responsible for creating science driven project plans jointly with DS, DP, RA & QA line functions.
- Enable CMC-team effectiveness through active prioritization, robust development strategies & supply plans, effective risk-management and appropriate resourcing. Ensuring realistic analytical timelines, capacities and deliverables in CMC project plan
- Define analytical control strategy in line with the overall project plan, strategic priorities, SOPs and regulatory expectations
- Provide timely analytical input to project governance meetings. Represent analytical function in the project meetings. Communicate potential risks and mitigation strategy
- Lead analytical scientists in a matrix environment. Mentor / provide technical guidance to colleagues (in- and outside ARD)
- Support TRD/ARD strategic priorities for operational excellence and simplification. Supporting rollout of D&D tools
- Work according to appropriate SOPs, GMP, GLP, QM, HSE, & Novartis Guidelines
Essential Requirements:
- Master of Science / Pharmacy or equivalent and 20+ yrs pharma Industry experience
- Good knowledge of English : oral and written
- Proficient in Analytical development .Good knowledge of software tools
- Good presentation skills and scientific/technical writing skills
- Strong Leadership skills
- Desirable: Advanced degree (Ph.D. or equivalent)
Skills Desired
Budget Management, Coaching Skills, Data Science, Experiments Design, Laboratory, Problem Solving Skills, Process Simulation, R&D, Waterfall Model
