Downstream Manufacturing Associate II (Contract)

Rentschler Biopharma•Milford, MA

2d•$32 - $45•Onsite

About The Position

The Manufacturing Associate II, Downstream Purification is focused on biologics manufacturing, specializing in 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 operates manufacturing process equipment to perform various manufacturing production steps, monitors and records batch parameters, troubleshoots process problems, and orders, receives, and distributes supplies. The position also involves training other team members, participating in team meetings, conveying information to external stakeholders, and participating on Continuous Improvement Teams. Knowledge of laboratory and pharmaceutical production equipment, including autoclaves, process tanks, chromatography skids and columns, and analytical equipment, is required. Familiarity with standard troubleshooting approaches is also necessary.

Requirements

With high school diploma: Normally requires 1-4 years of related experience required or an associate degree in Life Sciences/Engineering field.
With Bachelor’s degree: Normally requires 0-2 years of related experience.
Good with Microsoft Office – Outlook, Word, Excel.
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.
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

Nice To Haves

Biotech Certificate preferred.

Responsibilities

Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).
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. (During Production Processing these activities may increase)
Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, analytical equipment.
Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
Such additional responsibilities as the Company may also assign.