Manufacturing Associate I, Buffer & Media Prep (Mon-Fri, 1st Shift - Contract)

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

Duties And Responsibilities

• Key areas of responsibility include but not limited to preparation of buffer and media, weigh and dispense, operating the glass washer and autoclave, and supporting manufacturing teams as needed.
• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical material or validation activities).
• Operate manufacturing process equipment to perform various manufacturing production steps.
• Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines.
• Order, receive and distribute supplies into production area as needed.
• May perform other duties as assigned. (During Production Processing these activities may increase)
• Knowledge of laboratory and pharmaceutical production equipment included but not limited to autoclaves, glass washer, process tanks, and analytical equipment.
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
• Possess good knowledge of cGMP and cleanroom behavior
• Such additional responsibilities as the Company may also assign.

Qualifications

• With high school diploma: 1 years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred.
• 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.
• 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

Working Conditions

• Personal Protective Equipment must be worn as required
• May require lifting amounts of 25 lbs.
• Manufacturing operations tasks requires operator to regularly remain on feet for shift.
• Pushing buffer containers ranging from 50L to 200L.
• Sitting for periods of 2 to 3 hours.
• 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.

Physical Requirements

• PPE as required.
• May require lifting amounts of 25 lbs.
• Manufacturing operations tasks requires operator to regularly remain on feet for shift.