Lead Manufacturing Associate - Lyophilization

Responsibilities

• Lead, plan, and perform production activities for lyophilization
• Provide technical support for any lyophilization process-related issues
• Responsible for revising and originating production records, standard operating procedures, protocols and reports; initiates and closes out deviation reports and change requests
• Ensure lyophilization equipment is in controlled state to sustain manufacturing and ensure routine PM is executed on time
• Perform investigation and troubleshooting of technical issues in lyophilization with the identification and implementation of corrective actions
• Collaborate with Product Development team to transfer new processes to manufacturing and generate production records and SOPs in compliance with ISO 13485
• Generate risk assessments and mitigation plans when processes are transferred to Manufacturing
• Facilitate continuous improvement of processes to increase efficiency, improve quality and promote sustainability
• Train new manufacturing staff on procedures, aseptic techniques, equipment and trouble-shooting skills
• Cook with coordination with Facilities, QC and R&D to complete all pre- and post-production activities
• Perform final review of manufacturing MPRs for accuracy and filing of records
• Adhere to best safety practices and documented procedures to ensure a safe working environment

Requirements

• Bachelor’s degree or above in biological sciences, chemical engineering or related discipline
• 7+ years’ experience in pharmaceutical or biotechnology manufacturing or equivalent experience with minimum 4 years of hands-on experience in lyophilization
• Knowledge of Good Manufacturing Practices
• Experience in formulation and scale up
• Good analytical skills to interpret manufacturing data and understand production problems
• Experience with process development, transfer and optimization preferred
• Mechanical aptitude on performing troubleshooting and PM on lyophilizers preferred
• Excellent communications skills and good attention to detail
• Ability to work in fast paced, dynamic, team environment
• Ability to handle multiple projects at one time
• Proficient in MS Office (Word, Excel, and PowerPoint)

Preferred Qualifications

• Hands‑on familiarity with process characterization, scale‑up, and validation readiness activities (e.g., support of IQ/OQ/PQ planning or execution)
• Practical experience driving or supporting continuous improvement initiatives within a manufacturing or operations organization
• Demonstrated ability to lead cross‑functional teams by influence, aligning Manufacturing, Quality, Engineering, and Supply Chain toward shared objectives