Night-Shift Downstream Manufacturing Associate III

Rentschler Biopharma Inc.; Milford (CT); On-site; USD 49,924,000 - 73,553,000; Full time

Benefits offered by this job

Discretionary bonus

Medical insurance

401(k) program

Job summary

Rentschler Biopharma Inc. is seeking a Manufacturing Associate III focused on biologics downstream purification. You will perform operations under cGMP guidelines, train staff, and monitor batch parameters while collaborating across multiple teams in a 6pm–6:30am overnight schedule.

The role requires experience with GMP downstream manufacturing, Akta Ready/Process systems, and XDUOS buffer technologies. Strong documentation and teamwork are essential.

Qualifications

• High school diploma with 6+ years of related experience or an associate degree in Life Sciences/Engineering
• Bachelor’s degree with 4+ years of related experience
• Familiarity with cGMP manufacturing and lab equipment
• Strong written and verbal communication; able to read detailed instructions
• Proficient in MS Word and Excel; able to document data clearly
• Able to work in a clean-room environment and adhere to PPE protocols

Responsibilities

• Perform downstream manufacturing operations for commercial, development, clinical or validation activities.
• Train employees and serve as a subject-matter expert operating production equipment.
• Monitor and record batch parameters and perform related GDP/GMP documentation.
• Initiate new documents and revise existing procedures.
• Collaborate with support teams on investigations, inventory counts and discrepancies.
• Troubleshoot process issues and respond to alarms using event-management software.
• Oversee training and ensure staff competency before process execution.
• Manage supplies in the production area and handle buffer containers (50L–200L).
• Coordinate information flow with auditors and global colleagues; support cross-functional teams.

Skills

cGMP manufacturing

Data entry

Microsoft Word

Microsoft Excel

Attention to detail

Team collaboration

Education

High school diploma or equivalent with 6+ years of related experience

Bachelor’s degree in Life Sciences/Engineering

Biotech certificate preferred

Tools

Akta Ready

Akta Process

XDUOS buffer systems

Disposable technology systems

Job description

Rentschler Biopharma Inc. is seeking a Manufacturing Associate III focused on biologics downstream purification. You will perform operations under cGMP guidelines, train staff, and monitor batch parameters while collaborating across multiple teams in a 6pm–6:30am overnight schedule.

The role requires experience with GMP downstream manufacturing, Akta Ready/Process systems, and XDUOS buffer technologies. Strong documentation and teamwork are essential.