Manager Formulation Development and Research

Experience -

Qualification -

Responsibilities

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

Desired Skills

• 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