Scientific Director, AD, TDS-Synthetics

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmaceutical Product R&D

Job Category:
People Leader

All Job Posting Locations:
Mumbai, Maharashtra, India

Job Description:

Major duties/responsibilities:


* Lead one of the sub-team of Higi ONE AD organization, which is tasked with developing and validating chromatographic methods for all late-stage synthetic compounds in the portfolio of the Higi ONE AD team.

This includes method transfers, overseeing stability studies, conducting clinical release and stability testing and providing the analytical reports required for NDA/MAA filings, such as test method description, validation and stability reports.


* Performing late-stage development activities at Higi site which is just before the filing/submission will require working in a GMP environment, supporting different Health Authority inspections.


* He/she will collaborate with the other sub team leaders under Higi ONE AD organization to ensure that similar practices and methodologies are employed for all compounds supported by the Higi ONE AD organization.


* People Development: Identify training needs and opportunities for team members, provide coaching, and support their professional development to enhance skills relevant to method development/validation and stability studies.


* Project Management: Oversee the planning and execution of method validation, transfers and stability studies, ensuring high quality output, timely delivery of results and compliance with regulations.


* Manage the team's budget and resources effectively, ensuring cost-efficient use of technologies and materials.


* Strategic Planning: Develop and refine the overall strategy for the team aligned with organizational goals, ensuring that method validation, transfers and stability studies meet required standards.


* Team Leadership: Foster a positive team environment by providing direction, motivation, and support to team members.

Facilitate collaboration, both within Higi AD and with external teams, and ensure clear communication within the teams.

Other Duties:


* Direct Responsible Individual for new modality programs (ADC’s, Peptides).

In this role, he/she is the Single Point of Contact for other departments for their programs.


* Strengthen the interface between Analytical Development and key stakeholders (PQM, IMSC).

Key Working Relationships:


* Team Le...