Must know process validation cleaning validation verification and hold time studies. Candidate should also have exposure to EU, MHRA, and USFDA regulatory audits.
Proven track record of leading a large, geographically diverse sales team, including at least 2 years of experience overseeing half of India with a positive P and L outcome. Expertise in developing sales strategies, financial acumen, performance management, strategic project leadership, building and nurturing stakeholder relationships.
The candidate must possess a thorough understanding of relevant disease biology, the clinical landscape, emerging technologies, and the competitive environment.
This also includes managing the Per-Subject Cost PSC process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or pCRO and collaborating with other lines to plan site contracting timelines through start-up.
Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market. Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action. Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
Analytical Development Scientist with some supervision from the Analytical Development Lead focuses on the analysis of route scouting and Chemical Process Development of Bayers existing and pipeline crop protective agents. Collaborates with all internal and external functional teams. Method development for new entities and in-process on GC, GC-MS, HPLC, and various analytical techniques.
Ensure projects are kicked off appropriately and required information defining the scope of the project is properly identified. Ensure that a project schedule encompassing project scope and associated details is accurately developed and regularly maintained.
Analyst worked in AMT, AMV section having exposure to HPLC, GC, IC, AAS. Analyst worked in GLP Section having exposure instrument calibration, Qualification, Standard Management, Working Standard qualification.
Otsuka Pharmaceutical India Private Limited primarily manufacturing IV and parenteral nutrition products across multiple markets and therapeutic segments.