Key Responsibilities:
- Experience in generic API product development for regulated markets
- Ability to guide and handle a team of about 50 chemists
- Working knowledge in IP and regulatory
- Experience in QbD, DOE based approach
- Knowledge of GMP, technology transfer and process validation
- Experience in handling OOS/OOT and other investigations
- Experience in reviewing DMF's and handling/responding to regulatory deficiencies
- Good communication, presentation and interpersonal skills
Qualifications:
PhD in Organic Chemistry/ Synthetic Organic Chemistry/ Chemistry from a reputed institute or university with more than 10 years of re relevant experience in API product development regulated market.
Behavioural/Managerial skills:
- Key strength shall be to provide efficient leadership for the technical and scientific team of people.
- Ability to communicate and influence to achieve delivery of objectives often to tight deadlines.
- To be able to maintain healthy rapport with internal & external stake-holders.
- Business acumen, Interpersonal Skills, and Result Orientation is something person must have.
- Thrive to achieve overall business goals for the organization with passion & self-motivation.
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