Senior Manufacturing Associate

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, Standard Operating Procedures, 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.
• Participate 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.

Qualifications

• A B.S. or B.A. degree in Biology, Chemistry or equivalent with 6+ years of relevant experience in reagents manufacturing.
• Experience in lyophilization highly preferred.
• Strong verbal and written communication skills.
• Able to work and deliver expected results with a high degree of autonomy.
• Able to handle multiple tasks and highly adaptive to changing priorities and deadlines.
• Strong organizational skills, detailed oriented, and problem-solving skills.
• Must be a strong team player, self-motivated with “can do” attitude, and willing to learn new techniques and concepts in a fast-paced environment.
• Effective leadership and collaboration skills and the ability to work cross-functionally across categories and internal stakeholders.
• Strong proficiency with Microsoft Office suite and experience using manufacturing software, databases and data analytics tools.
• Experience in ISO 13485 and GMP environment a plus.
• Previous experience with ERP System preferred.

Physical Requirements

• Able to lift up to 25 lbs.
• Position requires working in a standing position for long periods of time on a daily basis.

Pay

The base salary range for this full-time position is $85,000 - $100,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training.