Optimize Pharmaceutical Processes

2 days ago

Hyderabad Secunderabad Telangana, India beBeeProcess Full time US$ 90,000 - US$ 1,20,000
Process Development Specialist

We are seeking a dynamic and experienced professional in process development to join our team.

  • You will be responsible for providing critical inputs in process design, executing experiments, and collecting and interpreting data to facilitate smooth process scale-up and ensure effective process control. This role involves collaborating with cross-functional teams, utilizing Quality by Design (QbD) principles, and finalizing batch sizes and equipment trains for successful scale-up and technology transfer.

Key Responsibilities:

  • Demonstrate successful process scale up to ensure smooth execution of confirmatory & exhibit Batches on time.
  • Prepare documents required for confirmatory/ scale up batch at plant.
  • Perform Scale Up correlations for all unit operations from lab scale to plant scale.
  • Provide control strategy for Exhibit Batches based on Confirmation Batch (CB) results.
  • Analyse data and provide support in answering process related deficiencies ensuring on time response to regulatory agencies.
  • Develop process capabilities within team, train new joinee /freshers.

Requirements:

  • Masters/Bachelors/Ph.D in pharma.
  • Minimum 3-5 years of experience in Process development.

Technical Skills:

  • Experience in the development/ scale up/ technology transfer of products in relevant dosage forms or technologies.
  • Understanding of pharmaceutical process selection.
  • Ability to prepare technical protocols and reports.
  • Experience in process Engineering, Quality by Design (QbD) principles and risk assessment approaches.
  • Knowledge of International Council for Harmonisation (ICH) guidelines related to Product development or Process Development.
  • Experience in Formulation Development understanding of execution methodology (based on Critical Material Attributes, Critical Quality Attributes of products.
  • Experience in Analytical Research and knowledge on interpretation of the data.

Behavioral Skills:

  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Performance oriented and good at building, leveraging relationship.
  • Ability to work collaboratively with own team and cross-functional teams.
  • Committed to Learning & Coaching the team.
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