Manufacturing Associate II - Media Preparation (Nights)

Role Summary

Manufacturing Associate II - Media Preparation (Nights) supports processing steps and manufacturing activities in a Drug Substance facility operating on a 2-2-3 calendar rotation for 12-hour shifts (nights: 5:45 PM – 6:00 AM ET) at RTP. Roles are organized by biomanufacturing steps (Upstream/Cell Culture, Downstream/Purification, and Media & Solution Preparation) and performed in a cGMP environment to deliver therapies to patients.

Responsibilities

• Execute daily manufacturing activities by operating production equipment, performing process steps, and completing validation or qualification protocols in accordance with cGMP and SOPs.
• Document all manufacturing work accurately, including cGMP data, deviations, equipment usage, and processing details. Create, revise, and maintain batch records, SLRs, equipment logbooks, and other key documentation.
• Support in-process sampling and analysis, including routine measurements such as pH, conductivity, protein concentration, osmolality, and cell counts.
• Maintain a clean, safe, and audit-ready workspace by following safety guidelines, good housekeeping practices, and compliance expectations.
• Collaborate as a reliable team member, showing up with focus, accountability, and a willingness to support teammates and shared goals.
• Participate in training and development, building your own capabilities while helping strengthen the skills and readiness of the team.

Qualifications

• Required: Bachelor‚Äôs degree from an accredited college or university; or A BiWorks Certificate, associate‚Äôs degree, or High School Diploma (or equivalent) with a minimum of 6 months of directly relevant experience.
• Required: Experience in cGMP manufacturing, biotech, or pharmaceutical operations.
• Required: Ability to follow detailed procedures and uphold safety and compliance standards.
• Required: Familiarity with operating production equipment and maintaining manufacturing documentation.
• Preferred: Bachelor‚Äôs degree in Science, Technology, Engineering and Mathematics (STEM) from an accredited college or university.
• Preferred: Strong communication skills and a team-oriented mindset.

Education

• Bachelor‚Äôs degree from an accredited college or university (Required or Preferred as noted above).
• STEM degree (Preferred).

Skills

• Biomanufacturing operations experience and ability to work in a fast-paced, compliant environment.
• Strong documentation and record-keeping proficiency.
• Effective communication and teamwork abilities.