GMP Coordinator I

Job Summary

BioLegend is looking for detail-oriented GMP/Bioprocessing Coordinator for our GMP Suite production processes, including Formulation, Filling, and Finishing functions. This role will be responsible for planning and coordinating both routine and non-routine work orders. In addition, the coordinator will be trained on and regularly support the execution of regular production functions (hands-on work), in excess of 50% of the work week to start, to support demand as well as to understand and be a subject matter expert on the production process they coordinate.

While the role is a "Day Shift*", it is anticipated that production runs may be required to start earlier in the day or end later in the day than a standard Day Shift. The coordinator is required to have a flexible schedule and be able to support earlier or later schedules and, as needed, be available for Saturday or Sunday shifts, with as much advance notice as is practical for the business.

This is a highly team-oriented group that involves working closely with all core teams within the GMP Department as well as other departments such as Quality Assurance, Product Development, Planning, Purchasing, Receiving, Inventory Control, Custom Solution Team (CST), Packaging and Quality Control groups.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Follow all safety, GMP, quality management system, and company policies and procedures
• Maintain all batch records and other documentation that are essential to be in compliance with ISO13485:2016 and MDSAP regulations
• Coordinate work according to the schedule provided by various business functions such as manufacturing, planning, product and process development, and custom service teams
• Act as a liaison and active problem solver for various business functions, positively and successfully addressing any scheduling conflicts and constraints that may impact our ability to deliver high-quality products, on time and in the required quantities
• Perform preparation work for scheduled orders to ensure that they are started on time
• Ensure orders are completed, from planning start date, through production execution, to final QC and QA release to finish goods inventory, with an "On-time Delivery" target (OTD) of >99%
• Maintain laboratory equipment such as ensuring equipment is calibrated and approved for use ahead of the production start dates, and is available for processing orders
• Coordinate the maintenance, collaboration, and validation schedules with Manufacturing, Process Engineering, Facilities and Planning teams, and other stakeholders to ensure no disruptions to production order execution, e.g. prevent delays
• Review, manage, and count laboratory supplies, reconciling and cycle counting as required, including conducting month-end cycle counts
• Receiving materials and conducting receiving inspection, organizing/labeling, and updating logs
• Printing and inspecting labels for final product production
• General buffer preparation, formulation, and dispensing
• Washing lab glassware
• Data entry and production documentation completion tasks
• Perform internal audits
• Be a key member of the GMP audit team including internal, external, customer, and 3rd party quality management system audits
• Collect data and create routine reports for relevant departments e.g. monthly reports
• Various other tasks to ensure the productions run smoothly
• Supplement production output, be hands-on, to meet changing inventory and customer needs, and to stay updated on manufacturing processing techniques
• Other projects or responsibilities as may be required

iACT Competencies

• innovate - Be better, keep improving, be more efficient, creative, and be in the forefront of development
• Aspire - Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
• Collaborate - Foster teamwork, common goals, selflessness, communication and mutual support
• Transform - Adapt, learn, re-invent and change for future development and growth

Minimum Qualifications - Education and Experience

• 6 months of relevant experience in a laboratory, biotech manufacturing, and/or filling/bottling/packaging working environment

Preferred Qualifications - Education and Experience

• Associate's Degree in Biology, Biochemistry, Chemistry, or other related area
• 2 years of work experience in Biotechnology or life science industries and working knowledge of quality management systems including ISO 13485, MDAP, or cGMP regulations
• Demonstrated experience in the planning, coordination, and execution of complex production schedules with a 99% OTD
• Demonstrated ability to be detail-oriented, and organized, work well in small work groups, and adhere to timelines
• Advance pipetting skill
• Practical knowledge of planning, coordination, and execution of production or other schedules
• Knowledge of Good Documentation Practices (GDP)
• Knowledge of aseptic techniques in biosafety cabinets
• Ability to perform simple math calculations
• Ability to communicate effectively both orally and in writing with a broad cross-section of stakeholders, from front-line employees, and senior management, to external parties e.g. vendors and customers
• Practical knowledge of various software applications - Microsoft Office Suite of applications
• Experience with Enterprise Resources Planning (ERP) and/or Materials Requirements Planning (MRP) software
• Experience with raw material supply receiving and inspection processes

The annualpay range for this full-time position is $22.00 to $24.00. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

Work Environment & Physical Demands

Lab

While performing the duties of this job, the employee regularly works in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

What do we offer?