Manufacturing Operations Analyst II

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
• Organize data and prepare 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

Qualifications

• 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
• Able 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
• Able 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

Preferred Qualifications

• Experience with regulatory agency interactions preferred but not required.

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 annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.