- Senior
- Optionales Büro in Pune
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
Doctorate in Pharmaceutical Chemistry or Chemistry
Post Graduation in Chemistry or Pharmaceutical Chemistry
