Job Description Summary

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.

 

Job Description

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