Senior Technical Manufacturing Lead

1 day ago

Warangal Hyderabad Secunderabad Telangana Nizamabad, India beBeeTechnical Full time ₹ 1,04,000 - ₹ 1,30,878
Job Opportunity

The primary objective of this role is to provide technical oversight and leadership for the manufacturing process. This entails ensuring that all products manufactured at the platform or cluster are robust and comply with current GMP and regulatory requirements.

  • Stewardship: guarantee product stewardship for all products manufactured, and oversee end-to-end technical management of product manufacturing processes across their commercial lifecycle; provide strong technical guidance to ensure product and related packaging operations are maintained in compliance with current regulations.
  • Ensure technical governance of platform Manufacturing Robustness Review Board (MRRB).
  • Oversee the capability of manufacturing and packaging processes by monitoring Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) through a continued process verification program and review of Annual Product Reviews (APRs).
  • Guarantee the robustness of manufacturing and packaging processes, ensuring site products are validated and remain in a constant state of validation throughout the product lifecycle.
  • Act as the single point of contact for products within the site and across sites for multi-site products, addressing process technical issues.
  • Maintain and develop scientific information on product processes.
  • Support and lead optimization of pharmaceutical processes by applying sound scientific reasoning and following integrated process and technology strategies, triggering post-launch development when necessary.
Requirements

To be successful in this role, you will need:

  • Education (minimum/desirable): MSc. In Science, Pharmacy or Chemical Engineering,
  • Pharmaceutical Technology or equivalent experience. Ph.D. desirable.
  • Minimum 15 years experience in manufacturing. Additional specialist experience is preferred (e.g. pharmaceutical formulation, process development, manufacturing technology).
  • Cross Cultural Experience.
  • Strategy Development.
  • Leading large and/or diverse multi-functional teams.
  • People Leadership.
  • Collaborating across boundaries.
  • Operations Management and Execution.
Skills

You will also require:

  • Change Management.
  • Manufacturing Process Science.
  • Manufacturing Technologies.
  • Npd (New Product Development).
  • Process Simulation.
  • Project Management .
  • Quality Compliance.
  • R&D (Research And Development).
  • Technical Leadership.

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