Manufacturing Associate (Backhalf Day)

Role Summary

The Manufacturing Associate (Backhalf Day) role involves working on a shift with 6–10 peers to manage preparation of large-scale solutions (buffers and media), inventory of raw materials, and operation of process equipment in upstream or downstream areas to support daily operations. The position requires compliance with cGMP regulations, SOPs, product licenses, corporate policies, and safety practices, and includes shift work that may include weekends, off hours, and holidays.

Responsibilities

• Operate large scale bioprocess equipment for cell culture, purification, or buffer and media processing.
• Perform all aspects of processing with a broad understanding of science, compliance, and technical aspects.
• Display competency with process equipment and automated control systems.
• Perform cleaning and sterilization of parts and equipment used with the manufacturing process.
• Knowledge of biotech manufacturing processes and equipment, including cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations.
• Understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position.
• Proficiency with compliance; adherence to SOPs, batch records, good documentation practices, and data capturing.
• Process knowledge: understanding of process theory and equipment operation; ability to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance; and perform all aspects with broad understanding of scientific, compliance, and technical components.
• Support initiatives for process optimization and identify/elevate processing issues and support solutions.
• Demonstrated experience with automation systems (LIMS, MES, PI, etc.).
• Technical documentation: provide feedback to operational procedures; assist in incorporating new technologies, practices, and standards into procedures; capable of writing and reviewing process documents.
• Quality and compliance: understanding of cGMPs related to Clinical and/or Commercial Operations; ability to utilize quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• Business: participate on projects and contribute to outcomes; capability to learn and support new business systems (TrackWise, ERP, etc.); support trending of defined department metrics; other duties as assigned.

Qualifications

• 2 years of industry experience.

Skills

• Strong communication skills—verbal and written.
• Ability to work in a team environment with good conflict resolution and collaboration.
• Displays initiative to identify areas for improvement and implement solutions.

Education

• Bachelor’s degree in science related area or engineering or associate degree in science related area or biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry.
• Alternatively, 4 years of college or 2 years of biotechnology program.

Additional Requirements

• Shift details: Back half Day shift alternating Wed/Thu-Sat 6am-7pm.
• Onsite Only.
• Travel: No travel required.
• Physical demands: Potential for strenuous, repetitive work with lifting up to 25 pounds; frequent bending, reaching, climbing stairs and ladders, kneeling, and performing numerous equipment connections; PPE required.