Lead QC Associate II (Raw Materials)

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we collaborate 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 Quality Control group at FDBU group is seeking a Lead QC Associate II at our Bioprocess Innovation Center in Morrisville, NC. This position supports a broad range of analytical disciplines within the Quality Control 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 of difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity. The position primarily works with or may take direction from peers within the department, but may work more independently according to the schedule workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.

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 relayed 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 writing services (such as preparing reports and initiating deviations) from pre-existing templates.
  • Capable of meeting schedules with 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
  • Managers multiple assignments of increasing complexity and responsibility
  • Generate reports and recommendations based on statistical data, can identify statistically significant and impacting events
  • Performs or leads laboratory investigations, identifies deviations and implements corrective actions
  • Applies process improvement methodologies that contribute to solutions of technical issues
  • Can communicate in a manner that foster cooperation and creates a safe environment for those involved

Major activities and responsibilities

  • Laboratory sample analysis and data management – 90%
  • Other (training, projects, housekeeping, and related activities) – 10%

Background Requirements

Minimum Education Requirements

  • BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field

Desired Experience

  • 8+ years related laboratory experience (4 years required with relevant MS degree)
  • Experience with compendial analysis, USP, EP and JP, method validation/verification, FTIR, RAMAN, Karl Fischer, Polarimeter, and Refractometer

 

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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