Associate Director

Job Description

Job Responsibility:

• Ownership and accountability of all the analytical related research and development activities of complex injectable products such as Peptides, Iron complexes, Emulsions, Suspensions, Microspheres, Liposomes, In-situ gels, 505 (b2) products, Liquid injectable and Lyophilized injectables for regulated markets such as USA, Europe etc.
• Strategic planning and execution of projects and processes within the analytical team
• Scientific, regulatory and business oversight of analytical projects
• Co-ordinate with Formulation team, Quality control team, DQA, Regulatory affairs, Project management and other cross function teams of Lupin.
• Proactively enables the timely execution of analytical development projects, thereby facilitating timely regulatory submission and approval of products.
• Mentors the team and implements systems for continuous improvement of communication and analytical tools and methodologies.
• Envisions and establishes niche capabilities within analytical team

Skills:

• Experience in managing multiple teams for complex injectable analytical development
• Sound understanding regulatory affairs, injectable formulation, QA/QC systems and procedures
• Expertise in different analytical techniques that caters development of complex injectable products
• Ability to work with external customers
• Ability to provide a strategic direction to a large analytical team with necessary technical leadership
• Experience in setting up functional capabilities (Facility & Scientific) for analytical research and development.
• Recruitment of suitable candidates and budgeting

Work Experience

• Minimum 18 years of experience out of which a minimum of 8 years of experience in leadership role in Injectable profile

Education

Competencies