
Lead Pharmaceutical Formulation Development Specialist
15 hours ago
Job Title: Formulation Process Expert
Job Description:We are seeking a highly skilled Formulation Process Expert to join our team. The ideal candidate will have expertise in formulation development of various dosage forms with a strong knowledge of process optimization.
The successful candidate will be responsible for designing and optimizing manufacturing processes with technical improvements for regulated markets (US, Canada, EU) within allotted timelines. They will also evaluate manufacturing processes using DoE and QbD to define design space, control strategy, critical/key parameters, and identify process risks.
In addition, the candidate will be responsible for screening manufacturing sites based on formulation and process complexity/feasibility, leading technology transfer functions with adequate project management skills to ensure successful scale-up of new products and effective launches with stipulated time.
The role also involves defining procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches. Furthermore, the candidate will serve as an SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
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.
This is a challenging and rewarding opportunity for a motivated and experienced professional looking to take their career to the next level. As a key member of our team, you will have the opportunity to work on exciting projects and develop your skills in a supportive and collaborative environment.
Others:Please note that this job description may be subject to change based on business needs and requirements.
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