Job Description

Design, plan, perform, interpret and report results of scientific experiments for the method development of drug substances (DS) and drug products (DP) within global ARD. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals.

Major accountabilities:

• Develop and qualify various analytical methods (e.g., fast LC, titration, dissolution).
• Provide analytical and technical support to PHAD/project team at various stages of product development (e.g., CSF, FMI and LCM).
• Design and author analytical documents (e.g., Analytical methods, Stability protocols/reports, Excipient compatibility (EC) protocol/reports; APS protocols/reports, etc.)​
• Support Analytical project leader for setting analytical development strategy.
• Support in data interpretation, results compilations and sharing the information with critical observations and proposals to project team.
• Responsible for project related sample handling (e.g., sampling plans, issuance, storage, distribution, reconciliation/destruction of the samples)​
• Support planning for assigned project activities. Accountable to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned project activities.
• Provide requests for lab activities to the associates and stakeholders.
• Manage project activities including logistics at third parties and external testing laboratories.​
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
• Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines.
• Subway: Author (EC/APS protocol and reports), review of test methods and compatibility study plan.
• ESOPS:Read SOP accessand Review of SOPs.

Minimum Requirements:

• Recognized expertise in analytical methodology and broad scientific as well as technical and strategic background.
• Demonstrated successful experience with working in interdisciplinary and cross-cultural teams.
• Demonstrated leadership and advanced coaching and mentoring skills.
• Thorough knowledge of relevant SOP, GMP and Novartis regulations and policies if applicable.
• Excellent communication/presentation skills and scientific.

Education and experience

Ph.D in Chemistry/Pharmaceutical sciences with a minimum of 10 years of experience, or M. pharm/M.Sc. with 15 plus years of experience within the pharmaceutical industry, specifically in analytical development.

Languages :

• English.

Skills Desired

Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model