Job Overview
A highly experienced Technical Services Manager is required to coordinate and support the Development & Optimization of Pharmaceutical Manufacturing Processes, ensuring Compliance with Regulatory Standards, and driving continuous improvement initiatives.
Key Responsibilities
* Oversee the design, development, and optimization of pharmaceutical manufacturing processes, ensuring robust, scalable, and cost-effective production.
* Initiate and track the execution of process risk assessments (e.g., FMEA) and implement risk-mitigation strategies.
* Drive resolution for investigations into deviations, non-conformances, and root cause analyses.
* Lead technical aspects of scale-up, tech transfer, and commercialization of new products.
Validation & Compliance
* Ensure all process changes comply with cGMP, FDA, EMA, and other regulatory requirements.
* Provide SME support for regulatory filings (e.g., CMC sections of regulatory filings) with process data and technical justifications.
Manufacturing Support & Troubleshooting
* Manage on-the-floor technical support for routine manufacturing operations, deviations, and process issues.
* Collaborate with production and quality teams to ensure consistent process performance.
NPI, Technical Transfer & Scale-Up
* Guide and manage the technical requirements supporting technology transfers between development, pilot, and commercial-scale manufacturing.
* Collaborate with R&D, and Site Operations teams to ensure smooth process transitions.
Required Skills & Qualifications
* Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a 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 pharmaceutical manufacturing processes, terminal sterilization, and lyophilization.
* Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.