Pharmaceutical Formulation Development and Process Optimization Specialist

1 day ago

Kannur, Kerala, India beBeeFormulation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Opportunity

We are seeking a Pharmaceutical Formulation Development and Process Optimization Specialist to join our team. As a key member of our organization, you will be responsible for designing, optimizing, and scaling up pharmaceutical manufacturing processes for regulated markets (US, Canada, EU). Your expertise in formulation development, technology transfer, and project management will enable you to ensure seamless product transfers, robust scale-ups, and successful launches.

Responsibilities:
  • Process Optimization: Design and optimize manufacturing processes with technical improvements within allotted timelines.
  • Manufacturing Evaluation: Evaluate manufacturing processes using DoE and QbD to define design space, control strategy, critical/key parameters, and identify process risks.
  • Site Screening: Screen manufacturing sites based on formulation and process complexity/feasibility.
  • Technology Transfer: Lead Technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches with stipulated time.
  • Product Transfers: Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
  • Expert Guidance: Serve as SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
  • Standards Implementation: Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities, with CFTs.
  • Capacity Enhancement: Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  • SOP Review: Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines, technical changes, change control, deviations, and relevant documents.
Desired Skills:
  • Formulation Expertise: Expertise in formulation development of various dosage forms with strong knowledge of process optimization.
  • Technology Transfer: Hands-on experience in technology transfer and scale-up.
  • Regulatory Knowledge: Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.
  • Soft Skills: Excellent documentation, communication, and analytical skills.
  • Project Management: Ability to work in a fast-paced, dynamic environment.
  • Cross-Functional Coordination: Project management and cross-functional coordination.

We offer a competitive salary, opportunities for professional growth, and a collaborative work environment. If you have the required skills and qualifications, please apply for this exciting opportunity.

Key Qualifications
  • Bachelor's degree in Pharmacy, Chemical Engineering, or related field.
  • Minimum 5 years of experience in pharmaceutical formulation development and process optimization.
  • Proven track record of successfully designing and optimizing manufacturing processes.
  • Strong knowledge of regulatory guidelines and industry standards.
  • Excellent communication, documentation, and analytical skills.
  • Ability to work in a fast-paced, dynamic environment.

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