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 III serves as a senior subject matter expert within biologics manufacturing operations, providing strategic and operational leadership across all manufacturing teams. This role is responsible for overseeing the execution of complex manufacturing processes, ensuring consistent compliance with cGMP requirements, environmental health and safety (EHS) standards, and all applicable regulatory expectations.

In addition to advanced process execution and troubleshooting, the Lead drives operational excellence by proactively identifying and mitigating risks, leading deviation investigations, and ensuring timely and effective CAPA implementation. This role is accountable for coordinating cross-functional activities, optimizing workflows, and supporting continuous improvement initiatives to enhance efficiency, compliance, and overall process robustness.

The Manufacturing III provides direct guidance, mentorship, and training to associates, fostering technical development and reinforcing a culture of compliance and accountability. They serve as a key point of contact during critical operations, escalations, and audits, ensuring clear communication and alignment across departments.

This role maintains full ownership of production readiness and execution, ensuring that all manufacturing teams are consistently equipped with qualified materials, components, and equipment, while driving adherence to production schedules and minimizing operational disruptions.

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.
• 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.)
• 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
• May perform other duties as assigned. (During Production Processing these activities may increase)
• Possess good knowledge of cGMP and cleanroom behavior
• Such additional responsibilities as the Company may also assign

Qualifications

• With high school diploma: Normally requires 4-6 years of related experience or an associate degree in Life Sciences/Engineering field with 3-5 years related experience; biotech certificate preferred
• With bachelor's degree: Normally requires 2-5 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. 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

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