Manufacturing Associate 3, Column Packing

About the role

Build life-changing medicines with a team that trusts you to lead on the manufacturing floor. As a Manufacturing Associate 3 (Drug Substance Manufacturing), you’ll take ownership of critical processing steps, help bring new capacity online, and keep a 24/7 operation running safely, compliantly, and on time.

Job Description

We are a 24/7 biopharmaceutical manufacturing facility focused on bulk drug substance (Drug Substance Manufacturing, DSM). Our teams partner across functions to ensure safe, reliable, and compliant production in accordance with current Good Manufacturing Practices (cGMP).

Responsibilities

• Contribute to readiness for bulk drug substance manufacturing (systems, equipment, and documentation).
• Support projects such as: Reviewing and creating procedures. Developing or transferring manufacturing business processes. Supporting equipment and system testing and commissioning.
• Lead, execute, and document manufacturing processing steps and/or manufacturing support activities, including process monitoring and control.
• Perform in-process testing (for example: pH, conductivity, visual inspection).
• Execute validation protocols in alignment with cGMP Standard Operating Procedures (SOPs).
• Maintain all required training to perform assigned manufacturing activities.
• Absorb and assist in troubleshooting.
• Work shifts that include weekends and may include nights, in support of a 24/7 operation.

Minimum Qualifications

• Education and experience (one of the following): High school diploma or GED and 4 years of related experience in a manufacturing environment; or Associate’s degree; or Bachelor’s degree (BA/BS), preferably in Life Sciences or Engineering; or Associate’s degree plus 2 years of related experience in a cGMP manufacturing environment; or Equivalent military training or experience.
• Qualified experience in at least one unit operation: DPFG Filler; or Cell Culture – Seed Train.
• Knowledge, skills, and abilities: Ability to assist in troubleshooting. Strong verbal and written communication skills. Knowledge of production equipment operation relevant to assigned unit operations. Basic understanding of manufacturing run cadence and the order of shift activities. Knowledge of cGMP, safety, and operational procedures. Ability to work effectively in a team environment. Exercises considerable judgment and initiative; determines methods and procedures on new assignments; may act as an informal team leader.

Preferred Qualifications

• BioWorks or BTEC Capstone cGMP coursework.