Lead Manufacturing Specialist - Lyophilization

Alamar Biosciences, Inc.; Fremont (CA); On-site; USD 110,000 - 130,000; Full time

Job summary

An innovative firm is looking for a Lead Manufacturing Specialist in Lyophilization to enhance their operations team. This role involves overseeing lyophilization processes, training staff, and ensuring compliance with Good Manufacturing Practices. Ideal candidates will have extensive experience in the biotech or pharmaceutical sectors, particularly in lyophilization, and will thrive in a fast-paced environment. Join a mission-driven team dedicated to pioneering advancements in proteomics and contribute to groundbreaking discoveries in early disease detection.

Qualifications

• 7+ years in pharmaceutical/biotech manufacturing with 4+ years in lyophilization.
• Strong analytical skills and ability to interpret manufacturing data.

Responsibilities

• Lead and perform production activities for lyophilization.
• Provide technical support for lyophilization process-related issues.
• Train new manufacturing staff on procedures and equipment.

Skills

Lyophilization

Good Manufacturing Practices

Analytical Skills

Process Development

Troubleshooting

Communication Skills

Project Management

Education

Bachelor’s degree in Biological Sciences

Bachelor’s degree in Chemical Engineering

Job description

Join to apply for the Lead Manufacturing Specialist - Lyophilization role at Alamar Biosciences, Inc.

Get AI-powered advice on this job and more exclusive features.

About Alamar Biosciences, Inc.

At Alamar Biosciences, we’re on a mission to transform the field of proteomics for the early detection of cancer and other diseases. We are creating the world’s most sensitive proteomics platform to unmask the deepest secrets of our proteome. Our fully automated, high throughput platform will empower new biomarker discoveries for early detection and prevention of common diseases. We provide exceptional opportunities for those who have the entrepreneurial spirit, enjoy developing novel technologies and products, and aspire to grow together with the company.

Description

We are seeking an experienced, detail-oriented, and results-driven candidate to join our Operations team as Lead Manufacturing Specialist - Lyophilization. This position acts 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

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

Required Qualifications

1. Bachelor’s degree or above in biological sciences, chemical engineering or related discipline
2. 7+ years’ experience in pharmaceutical or biotechnology manufacturing or equivalent experience, with 4+ years of hands-on experience in lyophilization
3. Knowledge of Good Manufacturing Practices
4. Can follow/interpret SOPs and train manufacturing staff in lyophilization
5. Good analytical skills to interpret manufacturing data and understand production problems
6. Experience with process development, transfer and optimization preferred
7. Mechanical aptitude on performing troubleshooting and PM on lyophilizers preferred
8. Experience with execution of validation protocols is a plus
9. Excellent communication skills and good attention to detail
10. Ability to work in a fast-paced, dynamic team environment
11. Ability to handle multiple projects at one time

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.