Senior General Manager

Principal task and Responsibilities:

• Lead the Formulation Development and tech transfer team and activities for regulated market in Cadila Pharmaceutical Limited (US and Europe, Canada).
• Work on contract manufacturing projects of regulated markets with collaboration to all stakeholders.
• Responsible for evaluation of received NPD request from BD team and prepare techno Business Case.
• Responsible for end to end development of all products those are under New development and supplementary activities such as CRL, PAS, CBE30 for different regulated markets.
• Ensuring the team to follow all GLP, GMP compliances, SOP and guidelines. Responsibilities:
• Strategic development of globally acceptable formulation, which should be cost effective, time saving development.
• Development of QbD based high quality complex products for global markets (US & EU, AUS Canada).
• Responsible for monitoring of key milestones those directly and indirectly linked with project success.
• Lead a team for development of robust formulation and process through optimization and scale up studies well before start of validation batches.
• Timely do external collaboration with Contract development organizations, contract- manufacturing organizations, and clinical research organizations to avail their facilities to complete defined activities well within the timeline of each project.
• Explore knowledge of Design Expert software and other to all team members
• Actively support to technology transfer and production team (GMP area) for trouble shooting during scale up, exhibit batches and post approval batches.
• Organize project progress meetings with all stakeholders to understand technical criticality as well as update of all projects (Stage Gate Meetings).
• Address post-filling queries raised by Regulatory body well before the timeline.
• Actively discuss with clinical team about planning of clinical studies and its outcome for next line of action.
• Actively discuss with team leads and members about product complexities (which include IP, regulatory, Bioequivalence & formulations) and work design around alternatives to guarantee early product development and launch.
• To provide the technical support for commercial troubleshooting of products to technology receiving and production team
• Technical and non-technical support to senior management such as CAPEX and OPEX requirement.
• AlWays apply synergistic approach to boost intra and inter department team leads. members, and other cross-functional team members.
• Always make sound leadership qualities along vith strong decision-making power help organization to take calculate risk, which not only save time but also cost of company.
• Arrange several internal and external trainings for better knowledge updation of all team members.
• Review and approve documents like SOP, Sampling plan and tech transfer documents, stability study plan, Process validation protocol and Report timely.
• Provides documentation for the support of submissions. Performs technical review of product development report, plant CMC section of an ANDA/ANDA Supplement or other regulatory agency documents prior to forwarding to the Regulatory Affairs Department for inclusion in the ANDA/ANDA supplement submission.
• Ensures adherence to cGMP requirements, Guidelines, SOPs.