Lead Manufacturing Associate - Lyophilization

Description:

We are seeking an experienced, detailed oriented, and results-driven candidate to join our Operations team as Lead Manufacturing Associate - Lyophilization. This position act as the subject matter expert to commission new lyophilizers, train Manufacturing staff, drive continuous improvements for processes and equipment related to lyophilization and transfer of new products/processes into routine manufacturing. In addition, this position is also responsible for planning and executing lyophilization to meet production demand and overseeing other Manufacturing Associates in lyophilization. Experience in production planning and working under ISO 13485 and/or current Good Manufacturing Practice (cGMP) in a biotechnology or pharmaceutical industry is highly preferred.

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
• Coordinate 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

Required Qualifications:

• 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.

Physical Requirement:

• Ability to lift up to 25 lbs.
• Routine presence on the manufacturing floor, including extended standing or walking as required.

The base salary range for this full-time position is $110,000 - $130,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.