Lead Manufacturing Associate - Lyophilization

Description:

We are seeking an experienced, detail-oriented, and results-driven candidate to join our Operations team as a Lead Manufacturing Associate focused on lyophilization. This position will serve as the subject matter expert for commissioning new lyophilization equipment, training manufacturing staff, driving continuous process and equipment improvements, and transferring new products and processes into routine manufacturing. The role is also responsible for production planning and execution to meet demand while overseeing other Manufacturing Associates. Experience in production planning and operating within ISO 13485 and/or cGMP-regulated environments is highly preferred.

Responsibilities:

• Lead, plan, and perform production activities related to lyophilization.
• Provide technical support for lyophilization process-related issues.
• Revise and originate production records, SOPs, protocols, and reports; initiate and close deviation reports and change requests.
• Ensure lyophilization equipment remains in a controlled state and that preventative maintenance activities are completed on schedule.
• Investigate and troubleshoot technical issues, identifying and implementing corrective actions.
• Collaborate with Product Development teams to transfer new processes into Manufacturing and generate production records and SOPs in compliance with ISO 13485.
• Generate risk assessments and mitigation plans during process transfers.
• Drive continuous improvement initiatives to increase efficiency, improve quality, and support long-term sustainability.
• Train manufacturing personnel on procedures, aseptic techniques, equipment operation, and troubleshooting.
• Coordinate with Facilities, Quality Control, and R&D to complete pre- and post-production activities.
• Perform final review of manufacturing batch records for accuracy and document control.
• Adhere to safety policies and documented procedures to maintain a safe working environment.

Required Qualifications:

• Bachelor's degree or higher in Biological Sciences, Chemical Engineering, or a related discipline.
• 7+ years of pharmaceutical or biotechnology manufacturing experience, including at least 4 years of hands-on lyophilization experience.
• Strong knowledge of Good Manufacturing Practices (GMP).
• Experience with formulation and process scale-up.
• Strong analytical skills with the ability to interpret manufacturing data and troubleshoot production challenges.
• Experience with process development, process transfer, and optimization preferred.
• Mechanical aptitude and experience troubleshooting and maintaining lyophilization equipment preferred.
• Excellent communication skills and strong attention to detail.
• Ability to thrive in a fast-paced, team-oriented environment.
• Ability to manage multiple priorities simultaneously.
• Proficiency with Microsoft Office applications.

Preferred Qualifications:

• Familiarity with process characterization, scale-up activities, and validation readiness efforts, including support of IQ/OQ/PQ planning or execution.
• Experience leading or supporting continuous improvement initiatives within manufacturing operations.
• Demonstrated ability to influence and collaborate across Manufacturing, Quality, Engineering, and Supply Chain functions.

Physical Requirements:

• Ability to lift up to 25 pounds.
• Routine presence on the manufacturing floor, including extended standing and walking as needed.

Compensation & Benefits:

• Competitve base salary
• Bonus opportunity, equity participation, and comprehensive benefits package.
• Compensation will be based on location, experience, education, and relevant skills. Salary ranges may be adjusted based on role leveling during the hiring process.

Additional Requirement:

• Must be authorized to work in the United States and able to meet employment eligibility verification requirements.