Downstream Manufacturing Associate III (Overnight Wed-Sat Shift)

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

Company Overview

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. With a team of approximately 1,400 employees headquartered in Laupheim, Germany, and a site in Milford, MA, USA, we maintain a global footprint and a commitment to sustainability as part of the United Nations Global Compact.

Job Summary

Manufacturing Associate III focuses on biologics manufacturing, specifically downstream purification. Operators perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations. The position follows an overnight 4/3 schedule (6pm-6:30am, Wed-Sat; working every other Wednesday).

Key Experience

• Experience in GMP downstream manufacturing; especially with TFF and chromatography systems and purification of monoclonal antibodies.
• Familiarity with Akta Ready, Akta Process, XDUOS buffer systems, and disposable technology systems.
• Experience troubleshooting equipment and processes in a clinical manufacturing environment.

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, including computer data entry; complete relevant paperwork following GDP/GMP guidelines and perform mathematical calculations related to production processes.
• Initiate new documents for procedures and make minor revisions to existing documents.
• Collaborate with support teams on event investigations, inventory cycle counts and discrepancies.
• Troubleshoot process problems, respond to alarms, and provide information for unplanned events through event-management software.
• Oversee training of new employees, track training requirements and ensure proper training prior to process execution.
• Order, receive and distribute supplies into the production area as needed.
• Push buffer containers ranging from 50L to 200L; sit for periods of 2-3 hours.
• Convey information to external stakeholders (auditors, global colleagues, etc.).
• Oversee support for groups that support manufacturing (e.g., external cleaners).
• Lead continuous-improvement teams (5S, Gemba, OMT, etc.) and facilitate multidepartment discussions.
• Demonstrate procedures during training sessions and schedule departmental or process activities when appropriate.
• Provide knowledge in training process improvements, as the company may assign additional responsibilities.

Qualifications

• High school diploma: 6+ years of related experience or an associate degree in Life Sciences/Engineering; biotech certificate preferred.
• Bachelor’s degree: 4+ years of related experience.
• Demonstrated knowledge of cGMP manufacturing and laboratory/pharmaceutical production equipment.
• Ability to read and follow detailed written instructions and strong verbal/written communication skills.
• Legible, grammatically correct record entries; authored technical procedures and created forms.
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.).
• Proficient in Microsoft Word and Excel.
• Good interpersonal skills and ability to work effectively in a team environment.
• Ability to meet the required schedule, including shift, weekend, holiday work and overtime as dictated by the 365-day production schedule.
• Ability to work in a clean-room environment, comply with hygiene standards, use special garments and personal protective equipment.

Physical & Working Conditions

• Normal office conditions: computer, phone, files, fax, copier.
• PPE must be worn as required.
• May require lifting amounts of 25lb and remaining on feet for the duration of the shift.

Compensation

• Base Pay Range: $36/hr – $46/hr.
• Additional benefits include discretionary bonus, medical insurance, 401(k) program and other rewards aligned with total rewards.

Contact

For further information or to submit an application, contact the recruiting team at [e-mail].