Manufacturing Operations Analyst II

Requirements

• Bachelor's Degree or equivalent experience
• 3+ years of related experience
• Experience customizing SAP and has thorough knowledge of business processes within SAP
• Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing. Experience with chromatography processes, cell culture or single use technology required
• Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids, chromatography columns, and analytical equipment
• 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 English written instructions and have good verbal/written communication skills
• Experienced with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
• Knowledge of basic chemical and biological safety procedures
• Good computer skills, knowledge of Microsoft Word, Excel and quality systems
• 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 dict

Benefits

Additional Information

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 Operations Analyst is part of Milford's Manufacturing Operations group by participating in biologics manufacturing and development processes, proactively seeking opportunities for improvements, performing investigations, and coordinating manufacturing deliverables. Serves as manufacturing representative for various interdepartmental projects and initiatives. Duties and Responsibilities Collaborate in the mitigation of any Environmental, Health, and Safety (EHS) needs and risks Subject Matter Expert or experienced with some of all of the following process equipment when performing all upstream and/or downstream production steps such as: expansion of mammalian cells in roller bottles and flasks; automated and manual cell culture systems supporting cell growth, expansions, and harvesting systems; viral inactivation mixing systems various filtration steps, single use technologies, chromatography process, ultrafiltration/defiltration (TFF), chromatography column packing activities as well as buffer and media preparation Responsible for SAP improvements, training, and execution of inventory transactions for manufacturing Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence, documenting all phases. At times, to lead CAPA investigations Own manufacturing related change controls for new and existing products Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects Monitor and review record batch parameters, including computer data entry and quality release procedures Participate in data trending programs. Assist in the creation of batch records and SOPs for new and existing processes Work closely with production team to organize personnel for daily activities, as needed Act as a liaison between MFG and other departments for planning, projects and to resolve issues Support manufacturing team lead(s) during processing periods Participate in Continuous Improvement Teams (such as 5S, Gemba , LEAN etc.) Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers and cross functional teams; lead team meetings and facilitate multidepartment discussions Stay current with biopharmaceutical industry best practices and technologies

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