
Formulation Development Specialist
3 days ago
Job Title:
Formulation Development SpecialistJob Description:
The Formulation Development Specialist will be responsible for designing and optimizing manufacturing processes, evaluating process risks, and leading technology transfer functions.
Key Responsibilities:
- Develop and implement process improvements to ensure timely and cost-effective product launches.
- Evaluate manufacturing processes using statistical methods and quality by design principles to define critical parameters.
- Screen manufacturing sites based on formulation and process complexity/feasibility.
- Define procedures for seamless product transfers between development and manufacturing, ensuring robust scale-up and accurate filings.
- Serve as subject matter expert for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations.
- Define and implement standards for formulation technology transfer and serve as point of contact for formulation technology transfer activities.
- Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
- Review and approve departmental standard operating procedures to ensure compliance with regulatory guidelines and technical changes.
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.
Benefits:
At our organization, we offer a challenging and rewarding career opportunity for individuals who share our passion for innovation and excellence. Our company culture values collaboration, creativity, and continuous learning.
Requirements:
12-16 years of experience in formulation development and research, M.Pharm qualification.
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