Job Title: Senior Technical Services Manager
Job Summary:
We are seeking a highly experienced Senior Technical Services Manager to lead our technical operations. The ideal candidate will have a strong background in aseptic processing, terminal sterilization, and lyophilization.
Job Description:
The Senior Technical Services Manager will be responsible for coordinating and supporting the Development & Optimization of Aseptic Pharmaceutical Manufacturing Processes, ensuring Compliance with Regulatory Standards, and driving continuous improvement initiatives as well as technical transfer and New Product Introductions.
This role involves collaboratively providing input with cross-functional teams, including Production, Product Development, Quality, Regulatory and Engineering, to enhance efficiency, scale-up processes, perform NPIs and troubleshoot manufacturing challenges.
Key Responsibilities:
* 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.
* Oversee the preparation and execution of Process Validation (PV) protocols (e.g., PPQ) and Continued Process Verification (CPV).
Required Skills and Qualifications:
* 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.
* Experience in sterile injectables or biologics manufacturing.
Required Skills and Qualifications:
To succeed in this role, you will need:
* 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.
Nice to Have:
* Six Sigma or Lean Manufacturing certification.
* Experience with automation systems (e.g., SCADA, MES).
* Knowledge of process analytical technology (PAT).
If you are a motivated and experienced professional looking for a challenging opportunity, please submit your application.