Process Optimization Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeProcess Full time US$ 90,000 - US$ 1,20,000
Job Description:

We are seeking a skilled process development professional to join our team. The ideal candidate will have experience in process design, execution, and optimization.

Key Responsibilities:

  1. Develop and execute process optimization trials
  2. Execute scale up/ confirmatory batch and support pilot batch
  3. Apply engineering concepts during optimization and scale up

Collaborate with cross-functional teams to ensure smooth process scale-up and effective process control.

Finalize batch sizes and equipment trains for successful scale-up and technology transfer.

Ensure successful process scale up to facilitate 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.

Prepare Process optimization report & filing documents.

Analyze 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.

Imbibe young talent and support in the initial stages.

Required Skills and Qualifications:
  • Masters/Bachelors/Ph.D in pharma
  • 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.
Benefits:

Join a dynamic and experienced team of professionals dedicated to delivering innovative solutions.

Collaborate with cross-functional teams to drive business growth and success.

Enjoy opportunities for career advancement and professional growth.

Others:

Be part of a diverse and inclusive team culture that values collaboration, innovation, and continuous improvement.

Develop your skills and expertise through training and development programs.

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