Job Summary
The Associate Executive (Manufacturing Associate) executes routine biologics manufacturing tasks under supervision. Responsibilities include supporting upstream or downstream operations through cleaning, material prep, system assembly, and documentation.
Primary Responsibilities:
Process Execution
- Perform basic manufacturing tasks such as single-use system assembly, line setup, and equipment/component cleaning.
- Assist with media or buffer preparation including pH/conductivity checks, filtration, and container labeling.
- Operate and support glasswash and autoclave functions to ensure the availability of sterile components.
- Support equipment sanitization, tubing configuration, and staging of raw materials.
- Execute Master Batch Records (MBR) under cGMP, and document in detail through the use of SOPs and MBRs for each process step.
Compliance
- Complete logbooks, forms, MBRs accurately in accordance with current Good Documentation Practices (cGMP).
- Adhere to all gowning, cleanroom, and safety protocols.
Training & Development
- Participate in training and qualification activities to build proficiency in core GMP manufacturing tasks.
- Demonstrate willingness to learn new skills and assist other team members.
- The responsibilities listed below represent the core expectations of the role; however, this is not an all-inclusive list. The Senior Executive may be assigned additional duties and responsibilities as business needs evolve.
Education & Qualifications:
- Associate or Bachelor’s degree in a scientific or technical discipline preferred; high school diploma or equivalent with 1–2 years of relevant experience accepted.
- Work schedule may be fluid to support a 24/7 manufacturing operation, including weekends, nights, and holidays. Schedule changes may occur based on business needs. .
- 0–2 years relevant experience in GMP or manufacturing environment.
- Strong work ethic, willingness to learn, and teamwork orientation