FORMULATION AND DEVELOPMENT MANAGER (API)

QUALIFICATION:   Minimum of B.Sc., HND or equivalent in Chemistry, Biochemistry, Biological Sciences

JOB DESCRIPTION/RESPONSIBILITIES:

  • Develop robust formulations and processes for various dosage forms as required by the company.
  • Plan and contribute to project-related technical activities.
  • Review and approve technical documents including Product Development Report, and other relevant documents for regulatory filing purpose.
  • Interaction with procurement team, API and excipients manufacturers, Machine manufacturers, CROs and CMOs as needed.
  • Work proactively with other cross-functional groups to execute product/ process improvement and optimization, Product Lifecycle management, change controls associated with Manufacturing and Packaging master records, SOPs and protocols.
  • Create and review SOPs, as well as review appropriate system documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
  • Provide relevant documents to Regulatory Affairs in a timely manner for registration filings and Supplements filing.
  • Review of batch records, process characterization reports, Annual Product Quality Review Report, validation reports and investigation reports where necessary.
  • Participate in designing and approval of tablet punches and blister change parts.
  • Review Formulation Development Protocol, Processes and Report to ensure the Development of robust formulations and processes.
  • Plan and contribute to project-related technical activities by reviewing the activities where required.
  • Review of technical document and communications shared by procurement team, API and excipients manufacturers, Machine manufacturers, CROs and CMOs as needed.
  • Review of SOPs, appropriate system documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
  • Preparation and review of Product Dossier.
  • Review of batch records, process characterization reports, Annual Product Quality Review Report, validation reports and investigation reports where necessary.
  • Ensure Pharmaceutical Development Protocol preparation, execution and reporting.
  • Ensure document preparation i.e., SOPs, Protocols, Master Formula Records.
  • Review and/ or Approval of prepared document.
  • Review and/ or Approval of technical drawing (tools and change part), where needed.
  • Any additional task assigned by Management.

SKILLS REQUIRED:

  • Minimum of 5-8years of relevant experience in Pharmaceutical Development
  • Knowledge of Quality by Design (QbD) principles towards dosage form development, planning of trials by DOE for development and execution of trial batches.
  • Knowledge of current Good Manufacturing Practices.
  • Member of relevant professional body.

LOCATION: SAGAMU

All applications must be received before 20th of march, 2024 Applicants should forward their application to hremzor@gmail.com