Quality Control Scientist II

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 Quality Control department at FDBU is seeking a QC Scientist II. The ideal candidate is an independent contributor that takes direction from manager and matrix contributors regarding priority and strategy. They are responsible for well-defined projects that are task oriented and may be assigned as a project and client representative for QC. The individual may have some personnel oversight responsibilities as they relate to daily project execution activities. The individual designs and executes components of projects that include but are not limited to process and method improvement, analytical technology transfer, method qualification/validation, and other related laboratory initiatives. The QC Scientist II is specialized in multiple disciplines that contributes as a subject matter expert on those topics. The individual works with minimal direction and is responsible for achieving assigned milestones and project deliverables. The position has multiple project ownership and is responsible for execution and deliverables for all or part of the project components. The individual may supervise a team of junior analysts. This position will report to a manager or director in the QC department.

Responsibilities and duties include, but are not limited to:

  • Coach analysts regarding technical issues, compliance issues related to the purpose and execution of the methods
  • May supervise personnel performing analytical testing
  • Develop an understanding of how the method and its analysis relate to the process
  • Assure campaign readiness regarding project milestones, STM and data from readiness, and reference material suitability and takes necessary actions to rectify gaps.
  • Acts as a gatekeeper for assigned disciplines, assuring consistency to methods and forms that are transferred to QC Managers contract laboratory testing, assuring data is evaluated and reported properly.
  • Participates and takes lead role in trouble shooting and resolution of assay execution issues
  • Develops training curricula related to assigned disciplines
  • Develops documents such as protocols, test plans, summary reports, methods, procedures
  • SOP review for technology or discipline area
  • Supports the initiation of changes controls CAPAs, deviations, and lab investigations, acting as a content expert and assuring breadth and depth of the topic are appropriately defined
  • Maintain currency with regulatory and compendial requirements and pending changes
  • Prepares Analytical Review reports for APRs and other associated summary review documents
  • Designs and develops statistical applications for the monitoring and analysis of data, recognizing and reporting trends in assay performance and capable of addressing root cause
  • Facilitates cross-functional process improvement projects and method transfers
  • Collaborate with customers and colleagues
  • Maintains network within discipline area and maintains awareness of industry practices and trends regarding laboratory operations and method life cycles
  • Maintains expertise through personal self-improvement efforts, such as current literature searches, networking, conferences or seminars

Major Activities and Responsibilities

  • Coordinate and/or manager projects assignments – 70%
  • Support Quality System activities, such as CAPA’s, SOP development/revision/change controls, technical report preparation, method development or verification – 30%

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 Gel and Plate based Assays preferred
  • Previous supervisory experience preferred

Specific Skills and Competencies

  • Capable of high through-put and high quality, RFT work
  • Certified or capable of timely certification for Yellow Belt
  • Demonstrated subject matter expert in several analytical disciplines
  • Proficient technical writing skills
  • Ability to make informed and timely decisions independently
  • Effective communication skills with colleagues both within and outside of the department
  • Capable of recognizing process gaps and identifying/implementing improvements
  • Leadership traits that build and foster trust, respect, cooperation and collaboration across the organization
  • Able to collaborate productively with groups both within and outside of the department
  • Effective time and multiple task management
  • Coaching skills

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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