Job Description:
We are seeking a talented professional to lead the development and optimization of aseptic pharmaceutical manufacturing processes. The successful candidate will oversee the design, development, and optimization of these processes, ensuring compliance with regulatory standards and driving continuous improvement initiatives.
This role involves working collaboratively with cross-functional teams to enhance efficiency, scale-up processes, perform New Product Introductions, and troubleshoot manufacturing challenges.
Responsibilities:
1. Process Development & Optimization: Develop and optimize aseptic/sterile pharmaceutical manufacturing processes to ensure high-quality products.
2. Risk Management: Identify and mitigate process risks through effective risk assessments and implementation of risk-mitigation strategies.
3. Investigation and Resolution: Lead investigations into deviations, non-conformances, and root cause analyses to drive resolution and prevent recurrence.
4. Technical Leadership: Provide technical guidance on scale-up, tech transfer, and commercialization of new products.
Requirements:
1. Education: Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
2. Experience: 5-8 years in pharmaceutical manufacturing, process engineering, or technical services; experience in sterile injectables or biologics manufacturing.