Job Description

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

The Manufacturing Associate II, Buffer Media Services is focused on biologics manufacturing, specializing in preparation of buffers and media to support cell culture and purification teams. In addition, the role is expected to provide support to central services team for glass washer and autoclave and weigh & dispense operations. Other duties may be assigned as needed within manufacturing operations, including supporting upstream and downstream. Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.

Duties and Responsibilities

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale, or validation activities).
• Prepare buffers and media, perform weigh-and-dispense activities, and support manufacturing teams as needed.
• Perform applicable operations for commercial-scale products, development studies, clinical materials, or validation activities.
• Supports monitoring and documentation of batch-related activities, including data entry in electronic systems, and completes required documentation in accordance with GDP and cGMP guidelines.
• Provide expertise as a SME as a part of training sessions for other team members,
• Communicates effectively with external stakeholders (e.g., auditors and global colleagues) and collaborates with cross-functional groups to support manufacturing operations.
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.).
• Experience with SAP and Master Control a plus .
• Proficient in performing SOP/MPR updates along with assisting with CAPAs and MOCs as needed .
• 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.
• Strong knowledge of laboratory and pharmaceutical production equipment included but not limited to process tanks, SUMs, pumps, Fiter Integrity Testers, tube management, and analytical equipment.
• Operate manufacturing process equipment to support various production steps.
• Monitor and record batch parameters, including required computer data entry, and complete all relevant documentation in accordance with GDP/GMP guidelines.
• Develop subject matter expertise on benchtop equipment.
• Train newer or less experienced technicians on applicable processes and procedures.
• Create and revise controlled documents, including SOPs, MPRs, and forms with-in Master Control.
• Lead other technicians during operations when a Lead Operator or Supervisor is not available.
• Communicate effectively with cross-functional teams.
• Perform required SAP transactions accurately and in a timely manner.
• Maintain required training, including OJTs, RAs, RUs, Compliance Wire, and Workday assignments, in an up-to-date status.
• Order, receive, and distribute supplies to production areas as needed.
• Possess good knowledge of cGMP and cleanroom behavior .
• Such additional responsibilities as the Company may also assign.

Qualifications

• With high school diploma: Normally requires 2-4 years of related experience required or an associate degree in Life Sciences/Engineering field with 1-3 years of related experience. Biotech Certificate preferred.
• With bachelor's degree: Normally requires 1-2 years of related experience.
• 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.
• 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
• Good with Microsoft Office – Outlook, Word, Excel.
• Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Working Conditions

• Personal Protective Equipment must be worn as required.
• May require lifting amounts of 40 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 40 lbs
• Manufacturing operations tasks requires operator to regularly remain on feet for shift.

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Base Pay Range

$32/hr - $37/hr

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The salary pay range is subject to change and may be modified at any time.