QC Lead Associate II (Chromatography)

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 2 will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing 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: 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 scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.

This position will provide testing support in the chemistry laboratory across multiple chromatographic disciplines. This is a 1st shift position. GMP Experience is required.

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 multiple assignments of increasing complexity and responsibility
  • Generate reports and recommendations based on statistical data, can identify statistically significant and impactful 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 fosters cooperation and creates a safe environment for those involved

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)

Specific Skills and Competencies

  • Possesses an understanding and knowledge of procedures and practices in assigned area
  • Has developed basic technique skills and is capable of working within established procedures
  • Capable of working with a moderate degree of supervision and organizing own time
  • Familiarity with basic statistical tools to analyze data in relation to trends results
  • Familiarity with data management processes such as Trackwise or LIMS or capability to learn basic use and navigation within the systems.
  • Capable of identifying and escalating problems to superiors
  • Can manage one or more tasks in a manner that promotes effective schedule adherence.
  • Ability to manage changing priorities in a productive and positive manner
  • Can communicate effectively with colleagues in department, building frust and respect
  • Ability to learn and incorporate lean lab and six sigma principles into daily work environment.
  • Able to achieve Yellow Belt Certification within company six sigma program
  • Technical writing skills (write basic protocols, prepare complex reports without a template)
  • Problem solving and troubleshooting competencies
  • Able to make informed and timely decisions independently
  • Ability to contribute beyond own product/department
  • GMP experience

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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