Lead QC Associate II (Biochemistry)

Overview

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

The QC Lead Associate II will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing focused on biochemistry plate and gel based-assays in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Gel based protein separation, IEF, Plate Based Assays, (e.g. SDS-Page, ELISA, Western Blot). The position primarily works with or may take direction from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.

This is a day shift position with a schedule of Sunday to Wednesday from 8 a.m. to 6 p.m. or 9 a.m. to 7 p.m.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES:

 

• Laboratory sample analysis and data management- 90%
• Other (training, projects, housekeeping, and related activities) — 10%
• This position supports the manufacturing, revenue, and profit plans as they relate to the on-time and error free analysis of product and equipment related samples in the Quality Control Laboratory.

Other duties and responsibilities include:

 

• Responsible for a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills, disciplines, and procedures within assigned discipline area(s)
• Demonstrated subject matter expert and responsible for CAPA's, audit actions, deviations, lab investigations, method revisions, and other related Quality System activities
• Takes lead in problem solving and troubleshooting, makes recommendations for mitigation and improvement
• Support all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution and data review.
• Lead/SME for method transfers, method validations and method qualification.
• Embrace lean lab and six sigma principles and applies them to laboratory processes
• Reviews technical data and provides expert review and input to new methods and revisions. Creates data reviews, summary reports, and provides expert interpretation of data
• Notifies management and initiates events (such as deviations) in the quality systems
• Prioritizes and organizes work to deliver assignment according to established schedules and deadlines. May coordinate logistics associated with laboratory testing or supporting documentation with others in group
• May provide technical services (such as preparing reports and initiating deviations) from preexisting templates.
• Capable of meeting schedule RFT, high quality effort, taking initiative to communicate, coordinate, and adjust work efforts to achieve these objectives.
• Trainer within areas of proficiency
• Assists with deviations, lab investigations, procedure changes, method transfer planning
• May have some assigned project responsibilities, such as department representation, document development or review, troubleshooting, and protocol execution.
• Contributes to achievement of team goals and sense of teamwork within unit and across department
• Identifies and solves problems while informing and consulting with area management
• Conveys holistic view of data in context of validity, reliability, and impact relative to the batch at hand and other related batches and processes.
• Proactively identifies and implements improvements with minimal oversight
• Manages mu