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Associate Director (Pune LRP, MH, IN) at Lupin

Lupin · Pune, India · Onsite

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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

Competencies

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