Job Description
A Senior Technical Services Manager is required to coordinate and support the development & optimization of aseptic pharmaceutical manufacturing processes. This role involves providing input with cross-functional teams to enhance efficiency, scale-up processes, perform NPIs and troubleshoot manufacturing challenges.
Process Development & Optimization:
* Oversee the design, development, and optimization of aseptic/sterile pharmaceutical manufacturing processes.
* 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:
* Oversee the preparation and execution of Process Validation (PV) protocols (e.g., PPQ) and Continued Process Verification (CPV).
* Provide direction and expertise in the generation of change controls aligned with site procedures to support product/process changes
* Ensure all process changes comply with regulatory requirements.
* Provide SME support for 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.
* Analyze process data trends to drive continuous improvement and reduce variability in critical quality attributes.
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.
* Provide SME level guidance regarding the definition of critical process parameters and critical quality attributes for robust transfer and/or scale-up.
Continuous Improvement & Innovation:
* Support team members in the identification and implementation of process improvements using problem-solving methodologies.
* Evaluate and introduce new technologies to enhance efficiency, reduce waste, and improve yield.
* Support cost-reduction initiatives while maintaining quality and compliance.
Requirements
* 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.
Technical Skills:
* 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.
Soft Skills:
* Experienced in providing mentoring and direction to team members.
* Track record of delivering projects, safely & compliantly.
* Capability to set clear goals and manage multiple tasks.
Preferred Qualifications:
* Six Sigma or Lean Manufacturing certification.
* Experience with automation systems (e.g., SCADA, MES).