Upstream Manufacturing Associate III

Rentschler Biopharma•Milford, MA

1d•Onsite

About The Position

This position is focused on biologics manufacturing, which includes processing in upstream (cell culture) and downstream (purification). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply. This role will follow an overnight Pitman schedule, 6pm-6:30am.

Requirements

Demonstrated knowledge of CGMP manufacturing
Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment
Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military time
Able to read and follow detailed written instructions and have good verbal/written communication skills
Able to write legibly and grammatically correct entries on records.
Must be able to author technical procedures and create forms
Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
Good computer skills, knowledge of Microsoft Word, Excel
Good interpersonal skills and be able to work effectively and efficiently in a team environment
Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule
Ability to work in a clean room environment and comply with hygiene standards and use of special garments
Additionally, personal protective equipment must be worn due to safety requirements
With high school diploma: Normally requires 7+ years of related experience required or an associate degree in Life Sciences/Engineering field.
With Bachelor’s degree: Normally requires 4+ years of related experience
Good with Microsoft Office – Outlook, Word, Excel

Nice To Haves

Biotech Certificate preferred

Responsibilities

Operate manufacturing process equipment to perform various manufacturing production steps
Knowledge on initiating new revisions for procedures
Proficient operating inside of a BSC, sampling, and performing with aseptic techniques
Monitor and record batch parameters, including computer data entry.
Complete relevant paperwork following GDP/GMP guidelines
Troubleshoot process problems and respond to alarms.
Provide information for unplanned events, including entering data into event management software
Order, receive and distribute supplies into production area as needed
Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers.
Participate in (and may lead, as requested) team meetings and facilitate multidepartment discussions
Convey information to external stake holders (auditors, global colleagues, etc.).
Provide support for groups that support manufacturing
Participate on Continuous Improvement Teams
May perform other duties as assigned.