Job Description Summary

Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals. Execute and support developing the functional strategy and drive operational excellence in line with TRD vision and strategy.

 

Job Description

Major Accountabilities:

• Oversee and lead all activities of assigned teams /projects; meet customer needs.
• Work according to appropriate standards for quality, ethics, health, safety, environment, protection and information security; lead initiatives to ensure continuous improvement; all activities have to be aligned with organizational workflows and procedures.
• Evaluate and interpret results, draw relevant conclusions; supervise project related activities; perform complex tasks without having established procedures.
• Oversess and may also write protocols, scientific reports, lab procedures or process.
• related SOPs; write scientific documents intended for external partners or for generation of registration documents; interact with authorities -Communicate, address and solve problems within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
• For technical development units: Develop complex methods (lab or plant); lead the optimization of project related scientific /technical activities or processes, co-ordinate local team(s); guide development and implementation of new technologies.
• For GMP units: ensure compliance to cGMP.
• For technology focused role: Provide scientific and technical guidance; actively foster knowledge exchange.
• Develop, mentor and coach other scientific associates; present scientific /technical results internally and contribute to publications, presentations and patents.
• For project-focused role: Lead assigned teams; represent own technical function in teams and fulfill all project tasks and responsibilities related to the own discipline -Broadly uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways -Contributes to many cost center goals and objectives; may contribute to service line goals.

Minimum Requirements

• Ph.D. with 4-6 years of relevant postdoctoral and/or industry experience in pharmaceutical sciences, analytical chemistry, or a related discipline; alternatively, M.Pharm./M.Sc. with at least 8-12 years of relevant industrial experience
• Strong expertise in the qualitative and quantitative analysis of oligonucleotides, peptides, and small molecules using LC-MS, HRMS, and other advanced mass spectrometry-based analytical techniques.
• Demonstrated ability to develop, optimize, and execute sensitive analytical methods for impurity profiling and trace-level quantification of genotoxic impurities (GTIs), nitrosamines, and nitrites in drug substances and drug products .
• Sound understanding of mass spectrometry workflows, data interpretation, and structural elucidation.

 

Skills Desired

Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model