Job Title: Senior Technical Services Manager
A highly skilled professional is required to oversee the design, development, and optimization of aseptic/sterile pharmaceutical manufacturing processes. The ideal candidate will ensure robust, scalable, and cost-effective production while adhering to regulatory standards.
Key Responsibilities:
• Oversee the design, development, and optimization of aseptic/sterile pharmaceutical manufacturing processes.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
• Provide technical support for routine manufacturing operations, deviations, and process issues.
• Collaborate with production and quality teams to ensure consistent process performance.
• Analyze process data trends to drive continuous improvement and reduce variability in critical quality attributes (CQAs).
• Guide and manage the technical requirements supporting technology transfers between development, pilot, and commercial-scale manufacturing.
• Support team members in the identification and implementation of process improvements using Lean, Six Sigma, and other problem-solving methodologies.
Requirements:
• Bachelors or Masters degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
• 5 - 8 years of experience in pharmaceutical manufacturing, process engineering, or technical services.
• Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.
• Experience with process validation (PPQ), DOE, and statistical process control (SPC).
• Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.
• Excellent analytical and problem-solving skills.
• Ability to manage multiple projects in a fast-paced environment.
Benefits:
• Opportunity to work in a dynamic and innovative environment.
• Collaborative team culture that values continuous learning and improvement.
• Competitive salary and benefits package.