Senior Manufacturing Associate, Biotech, Second Shift

Alamar Biosciences, Inc.; Fremont (CA); On-site; USD 85,000 - 100,000; Full time

Job summary

Alamar Biosciences, Inc. is seeking a Senior Manufacturing Associate for the second shift in Fremont, CA. You will perform processing and conjugation of antibodies, lyophilization, and related manufacturing tasks in a GMP environment.

The role requires a BS in Biology or Chemistry with 6+ years of reagents manufacturing experience, strong autonomy, and solid communication. ISO 13485/GMP exposure is highly preferred; a lead role on weekends is possible with responsibility.

Qualifications

• BS in Biology or Chemistry with 6+ years of reagents manufacturing experience.
• Lyophilization experience preferred.
• Strong communication and ability to work autonomously.
• Able to adapt to changing priorities and deadlines.

Responsibilities

• Perform processing and conjugation of antibodies and lyophilization of critical components for downstream manufacturing.
• Formulate standard to complex biochemical and chemical reagents in accordance with manufacturing records, SOPs, and Quality System regulations.
• Assist in other manufacturing activities deemed high priority such as filling and packaging, label printing, and special builds, etc.
• Perform batch records review and sign off to ensure completeness and compliance to Quality System standards.
• Support production scheduling and assignment of job duties to team members.
• Provide training, mentoring, and coaching to team members with similar or less experience.
• Address and investigate production issues and report any compliance related concerns to supervisor and/or management as soon as possible.
• Ensure equipment and instruments are current with calibration and preventive maintenance, and general maintenance.
• Participate in verification and validation to transfer new products/processes from R&D into Manufacturing, including executing on protocols, gathering data and/or report generation.
• Initiate process improvement projects to improve productivity, quality, cost, or yield.
• Draft, review, or revise manufacturing documents and procedures.
• Perform change management as required to support product and process change and document change.
• Participation in the selection and training of new employees.
• Act as Lead when Specialist/Supervisor is unavailable.
• Participate in internal and external safety and quality inspections.
• Enforce a safe working environment and compliance with all safety laboratory practices.

Skills

Communication

Autonomy

Problem solving

Team player

Leadership

MS Office

Manufacturing software

Data analytics

Education

BS in Biology or Chemistry

Tools

ERP System

Manufacturing software

Job description

Alamar Biosciences, Inc. is seeking a Senior Manufacturing Associate for the second shift in Fremont, CA. You will perform processing and conjugation of antibodies, lyophilization, and related manufacturing tasks in a GMP environment.

The role requires a BS in Biology or Chemistry with 6+ years of reagents manufacturing experience, strong autonomy, and solid communication. ISO 13485/GMP exposure is highly preferred; a lead role on weekends is possible with responsibility.