Senior General Manager

Cadila Pharmaceuticals Limited; Dholka; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Cadila Pharmaceuticals Limited in India is seeking a senior formulation development leader to drive global-regulated markets development and tech transfer. You will lead a team through QbD, scale-up, and cross-functional collaboration from BD to regulatory for US, EU, Canada, and other regions.

The role emphasizes GLP/GMP compliance, strategic development of robust formulations, and timely execution of projects with external CDMOs/ CROs to meet milestones and regulatory timelines.

Qualifications

• Experience in global formulation development for regulated markets.
• Lead cross-functional teams across development, transfer and regulatory activities.
• Knowledge of GLP and GMP compliance and SOP adherence.
• Ability to manage timelines and coordinate with CDMOs / CROs.
• Experience with QbD-based development and scale-up studies.
• Strong communication with BD, regulatory, and clinical teams.

Responsibilities

• Strategic development of globally acceptable formulations with cost-effective approaches.
• Develop QbD-based high-quality products for US, EU, Canada.
• Monitor milestones linked to project success.
• Lead robust formulation and process development through optimization and scale-up before validation.
• Coordinate external collaborations with CDMOs, CMOs, and CROs to meet timelines.
• Support technology transfer to GMP production and troubleshooting.
• Organize progress meetings with stakeholders and manage Stage Gate reviews.
• Address regulatory post-filing queries and support clinical study planning.
• Provide technical support for commercial troubleshooting and management input.

Job description

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.