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. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

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

• 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

Qualifications

• With high school diploma: Normally requires 4 years of related experience required or an associate degree in Life Sciences/Engineering field; Biotech Certificate preferred
• With Bachelor’s degree: Normally requires 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

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; 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