Downstream Manufacturing Associate I (Contract)

Rentschler Biopharma • Milford, MA

10d

About The Position

The Manufacturing Associate I, Downstream Purification performs biologics manufacturing operations specializing in downstream purification. The role operates manufacturing process equipment and completes production activities for commercial-scale products, development studies, clinical-scale work, or validation activities, as applicable. All work must follow cGMP, environmental health and safety guidelines, and other applicable regulations.

The position is scheduled Wednesday through Saturday on a 4/3 day shift, from 6:00 a.m. to 6:30 p.m. The associate monitors and records batch parameters, completes required documentation, troubleshoots process issues, responds to alarms, and supports production-area supply needs. The role also contributes to training, team and cross-department discussions, continuous improvement, and communication with external stakeholders.

This work takes place in a clean-room manufacturing environment and requires compliance with hygiene standards and use of required personal protective equipment and special garments. The operator regularly remains on their feet during the shift, may lift up to 25 pounds, may push buffer containers ranging from 50L to 200L, and may sit for periods of two to three hours.

Requirements

• With a high school diploma, normally requires at least 1 year of related experience; alternatively, an associate degree in a Life Sciences or Engineering field is listed.
• Good working knowledge of Microsoft Office, including Outlook, Word, and Excel.
• Proficiency in a variety of mathematical disciplines and ability to use metric and U.S. measurement standards and military time.
• Ability to read and follow detailed written instructions.
• Good verbal and written communication skills; ability to write legibly and make grammatically correct record entries.
• Ability to author technical procedures and create forms.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment.
• Ability to meet the required schedule, which may include shift, weekend, holiday, and overtime work as dictated by the 365-day production schedule.
• Ability to work in a clean-room environment, comply with hygiene standards, and wear special garments and required personal protective equipment.
• Ability to meet the position's physical requirements, including regularly remaining on one's feet during the shift and possibly lifting up to 25 pounds and pushing buffer containers ranging from 50L to 200L.

Nice To Haves

• Biotech Certificate preferred.
• Knowledge of laboratory and pharmaceutical production equipment, including autoclaves, process tanks, chromatography skids and columns, and analytical equipment.
• Familiarity with standard troubleshooting approaches, including problem statements, root cause analysis, and corrections.

Responsibilities

• Operate manufacturing process equipment to perform production steps for commercial-scale products, development studies, clinical-scale work, or validation activities, as applicable.
• Initiate new revisions for procedures.
• Operate inside a BSC, perform sampling, and use aseptic techniques.
• Monitor and record batch parameters, including computer data entry.
• Complete paperwork in accordance with GDP/GMP guidelines.
• Troubleshoot process problems and respond to alarms.
• Provide information about unplanned events, including entering data into event management software.
• Order, receive, and distribute supplies in the production area as needed.
• Demonstrate procedures during training sessions for team members and potentially schedule department or process activities involving coworkers.
• Participate in team meetings and, as requested, lead them and facilitate multidepartment discussions.
• Communicate information to external stakeholders, including auditors and global colleagues.
• Support groups that support manufacturing.
• Participate in Continuous Improvement Teams.
• Perform other duties as assigned by the company.

Benefits

• Annual discretionary bonus program
• Medical insurance
• Generous 401K program
• Other benefits intended to support employees' personal and professional wellness

What This Job Offers

• Career Level: Entry Level
• Education Level: High school or GED