Job Title: Process Development Lead
Our client is seeking a seasoned Process Development Lead to oversee the design, development, and optimization of aseptic/sterile pharmaceutical manufacturing processes.
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)
• 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 cGMP, FDA, EMA, and other regulatory requirements
• Provide SME support regulatory filings (e.g., CMC sections of regulatory filings) with process data and technical justifications
• 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 (CQAs)
• 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 (CPPs) and critical quality attributes (CQAs) for robust transfer and/or scale-up
Required Skills:
• 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 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
• Proficient in the generation of cGMP documentation e.g. protocols, report, change control etc.
• Practical experience with filling machines, isolators, autoclaves, Depyrogenation tunnels, and Lyophilisers, modes of operation, critical process parameters etc.
• Good knowledge of aseptic behaviors, filter integrity testing, single use systems etc.
• Proficiency in data analysis tools (e.g., Minitab) and process modeling software
• Microbiological fundamentals and knowledge of unit operations to secure sterility assurance
• 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
• Strong analytical and problem-solving skills
• Excellent communication and cross-functional collaboration abilities
• Ability to manage multiple projects in a fast-paced environment
Preferred Qualifications:
• Six Sigma or Lean Manufacturing certification
• Experience with automation systems (e.g., SCADA, MES)
• Knowledge of process analytical technology (PAT)