Leading Pharmaceutical Process Expert

2 days ago


Solapur, Maharashtra, India beBeeFormulation Full time ₹ 1,80,00,000 - ₹ 2,00,00,000

Job Opportunity:

We are seeking a highly experienced and skilled Formulation Development Specialist to join our organization.

The ideal candidate will have a strong background in formulation development, with expertise in designing and optimizing manufacturing processes for regulated markets. They will also have excellent project management skills, with the ability to lead technology transfer functions and ensure successful scale-up of new products.

Key Responsibilities:

  1. Design and optimize manufacturing processes for regulated markets (US, Canada, EU) within allotted timelines.
  2. Evaluate manufacturing processes using DoE and QbD to define design space, control strategy, critical/key parameters, and identify process risks.
  3. Screen manufacturing sites based on formulation and process complexity/feasibility.
  4. Lead Technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches.
  5. Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
  6. Serve as SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
  7. Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities, with CFTs.
  8. Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  9. Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines, technical changes, change control, deviations, and relevant documents.

Required Skills and Qualifications:

  • Expertise in formulation development of various dosage forms with strong knowledge of process optimization.
  • Hands-on experience in technology transfer and scale-up.
  • Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.
  • Excellent documentation, communication, and analytical skills.
  • Ability to work in a fast-paced, dynamic environment.
  • Project management and cross-functional coordination.

About Us:

Our organization offers a range of services including contract research and development, contract manufacturing, and product life cycle management.



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