Developing a phase-appropriate control strategy for drug substances and drug products.
Collaborating effectively with stakeholders across various departments.
Coordinating comprehensive analytical activities, which involves generating physical and chemical data for materials, developing/improving and validating analytical test methods or other analytical controls and ensuring thorough documentation, timely delivery and adherence to quality standards
Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information.
Conduct work in compliance with cGMP where applicable, safety, and regulatory requirements.
Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs
Plan and document experiments/results independently and prepare for regulatory submissions such as IND and NDA.
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