Lead Manufacturing Specialist - Lyophilization

Job Description

Alamar Biosciences is seeking a Lead Manufacturing Specialist - Lyophilization to join their Operations team. The candidate will act as a subject matter expert, commission new lyophilizers, train manufacturing staff, and drive continuous improvements for processes and equipment related to lyophilization. This role also involves planning and executing lyophilization to meet production demand and overseeing other Manufacturing Associates. Experience in production planning and working under ISO 13485 and/or cGMP is highly preferred.Responsibilities include:

• Leading, planning, and performing production activities for lyophilization
• Providing technical support for lyophilization process-related issues
• Revising and originating production records, SOPs, protocols, and reports
• Ensuring lyophilization equipment is in a controlled state and routine PM is executed
• Performing investigation and troubleshooting of technical issues in lyophilization
• Collaborating with the Product Development team to transfer new processes to manufacturing
• Generating risk assessments and mitigation plans
• Facilitating continuous improvement of processes
• Training new manufacturing staff
• Coordinating with Facilities, QC, and R&D
• Performing final review of manufacturing MPRs
• Adhering to best safety practices

Required qualifications include:

• Bachelor’s degree or above in biological sciences, chemical engineering, or related discipline
• 7+ years’ experience in pharmaceutical or biotechnology manufacturing or equivalent
• 4+ years of hands-on experience in lyophilization
• Knowledge of Good Manufacturing Practices
• Ability to follow/interpret SOPs and train manufacturing staff
• Good analytical skills
• Experience with process development, transfer, and optimization (preferred)
• Mechanical aptitude on performing troubleshooting and PM on lyophilizers (preferred)
• Experience with execution of validation protocols (a plus)
• Excellent communication skills and attention to detail
• Ability to work in a fast-paced, dynamic team environment
• Ability to handle multiple projects at one time

The role offers:

• Bonus
• Equity
• Benefits