Job Title:
Aseptic Manufacturing Process Manager
About the Role:
We are seeking an experienced Aseptic Manufacturing Process Manager to oversee the design, development, and optimization of aseptic/sterile pharmaceutical manufacturing processes. This individual will be responsible for coordinating and supporting the Development & Optimization of processes, ensuring Compliance with Regulatory Standards, and driving continuous improvement initiatives.
Main Responsibilities:
* Oversight of process validation (PV) protocols and continued process verification (CPV)
* Leadership in scale-up, tech transfer, and commercialization of new products
* Direction and expertise in change controls and regulatory filings
* Technical support for routine manufacturing operations, deviations, and process issues
Requirements:
* Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or related field
* 5-8 years of experience in pharmaceutical manufacturing, process engineering, or technical services
* Experience in sterile injectables or biologics manufacturing
* Strong knowledge of aseptic processing, terminal sterilization, and lyophilization
* Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines
Benefits:
This role offers the opportunity to work in a dynamic environment, collaborate with cross-functional teams, and contribute to the success of our organization.
About Us:
We are a leading recruitment agency specializing in management and technical professionals for the life sciences sector.