(CW) Manufacturing Associate

Role Summary

(CW) Manufacturing Associate — The role involves supporting biopharmaceutical manufacturing processes, process optimization, and technical documentation within a cGMP-regulated environment.

Responsibilities

• Understand and learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance.
• Support process optimization initiatives and identify/elevate processing issues, contributing to solutions.
• Gain experience with automation systems (LIMS, MES, PI, etc.).
• Provide feedback and/or suggested changes to operational procedures; assist in incorporating new technologies, practices, and standards into procedures.
• Write and review process documents as needed.
• Understand and apply cGMP requirements related to Commercial Operations and utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• Participate in projects and contribute to outcomes; learn and support new business systems (TrackWise, ERP, etc.); assist in trending defined department metrics.

Qualifications

• Required: Understanding of process theory and equipment operation; ability to learn biopharmaceutical manufacturing processes; strong documentation skills.
• Preferred: Experience with automation systems and accuracy in maintaining quality systems within a regulated environment.

Skills

• Strong communication skills—verbal and written
• Ability to work in a team environment with good conflict resolution and collaboration
• Initiative to identify improvement opportunities and implement solutions

Education

• Bachelor’s degree in science-related field or engineering is nice to have.
• Associate’s degree in science-related field or biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry is nice to have.

Additional Requirements

• Hours: 6:00 PM to 7:00 AM, Alternating Sat/Sun - Tues
• Physical demands: Strenuous, repetitive work; lifting up to 25 pounds; potential exposure to loud equipment; use of personal protective equipment; shift-based/off-hour work