Manufacturing Associate III, Buffer Media Services (3-6 Month Contract)

Rentschler Biopharma SE; Milford (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Rentschler Biopharma SE is seeking a Manufacturing Associate III to lead and optimize biologics manufacturing operations at our Milford, MA site. You will oversee complex processes, ensure cGMP compliance, and drive continuous improvement while coordinating with cross-functional teams.

The role requires hands-on execution, mentorship of technicians, and strict adherence to GDP/GMP standards in a fast-paced production environment.

Qualifications

• High school diploma with 4–6 years of related experience, or associate degree with 3–5 years in Life Sciences/Engineering.
• Bachelor's degree with 2–5 years experience.
• Proficient in GDP and GMP guidelines and documentation.
• Able to perform weigh-and-dispense activities and buffer/media prep.
• Strong communication and teamwork skills.

Responsibilities

• Operate manufacturing process equipment to support production steps.
• Prepare buffers and media; perform weigh-and-dispense activities.
• Monitor batch parameters and document data entry per GDP/GMP guidelines.
• Lead other technicians during operations when a Lead Operator is unavailable.
• Coordinate cross-functional activities and support CAPA and MOC processes.

Skills

GMP experience

SOP writing

CAPA investigations

SAP transactions

Data entry in electronic systems

Team leadership

Education

High school diploma

Associate degree in Life Sciences/Engineering

Bachelor's degree in Life Sciences/Engineering

Biotech certificate

Tools

SUMs

Pumps

Process tanks

Filter Integrity Testers

Tube management

Analytical equipment

SOPs/MPRs documentation tools

Job description

locationsMilford, MA, United Statestime typeVollzeitposted onGestern ausgeschriebenjob requisition idJR2812Advancing 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 ResponsibilitiesPerform 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 operationsFamiliar 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 neededAbility 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 scheduleStrong knowledge of laboratory and pharmaceutical production equipment included but not limited to process tanks, SUMs, pumps, Fiter Integrity Testers, tube management, and analytical equipmentOperate manufacturing process equipment to support various production stepsMonitor and record batch parameters, including required computer data entry, and complete all relevant documentation in accordance with GDP/GMP guidelinesDevelop subject matter expertise on benchtop equipmentTrain newer or less experienced technicians on applicable processes and proceduresCreate and revise controlled documents, including SOPs, MPRs, and forms with-in Master ControlLead other technicians during operations when a Lead Operator or Supervisor is not availableCommunicate effectively with cross-functional teamsPerform required SAP transactions accurately and in a timely mannerMaintain required training, including OJTs, RAs, RUs, Compliance Wire, and Workday assignments, in an up-to-date statusOrder, receive, and distribute supplies to production areas as neededMay perform other duties as assigned. (During Production Processing these activities may increase)Possess good knowledge of cGMP and cleanroom behaviorSuch additional responsibilities as the Company may also assignQualificationsWith 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 preferredWith bachelor's degree: Normally requires 2-5 years of related experienceProficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military timeAble to read and follow detailed written instructions and have good verbal/written communication skillsAble to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create formsGood computer skills, knowledge of Microsoft Word, ExcelGood interpersonal skills and be able to work effectively and efficiently in a team environmentWorking ConditionsPersonal Protective Equipment must be worn as requiredMay require lifting amounts of 40 lbsManufacturing operations tasks requires operator to regularly remain on feet for shiftPushing buffer containers ranging from 50L to 200LSitting for periods of 2 to 3 hoursAbility 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 requirementsPhysical RequirementsPPE as requiredMay require lifting amounts of 40 lbsManufacturing operations tasks requires operator to regularly remain on feet for shiftBrauchen Sie Hilfe?Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team: [e-mail]