Manufacturing Operations Analyst II

Rentschler Biopharma•Milford, MA

18h•Hybrid

About The Position

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.

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 dictated by the 365-day per year production schedule
Ability 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

Nice To Haves

Experience with regulatory agency interactions preferred but not required.

Responsibilities

Collaborate in the mitigation of any Environmental, Health, and Safety (EHS) needs and risks
Serve as Subject Matter Expert or experienced with some or 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