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Scientist I, Bioassay Analytical Development

Employer
FUJIFILM Diosynth Biotechnologies
Location
Research Triangle Park, NC
Start date
May 19, 2022

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Job Details

The Bioassay Development group is seeking a Scientist II with experience in cell-based assays, ELISAs and Plate-based testing. The Scientist II independently designs, executes, and interprets complex laboratory experiments and development activities with priorities set by supervisor to achieve project goals. The individual demonstrates a practical understanding of own scientific discipline and applies knowledge in support of product development and new technologies. The Scientist II has broad experience in cell-based assays, ELISAs and Plate-based testing. The successful candidate will primarily be responsible for the development and qualification of assays for the characterization and identity, purity, and strength assessment of recombinant protein drugs.

External US

The Fujifilm Diosynth Biotechnologies, USA Bioassay Development group is seeking a skilled scientist to fill an exciting technical leadership role as Scientist II located at the Bioprocess Innovation Center in Morrisville, North Carolina.

The position will also be engaged in client interactions, provide sample testing support to process development, independent generation of analysis reports and other documentation. The successful candidate will act as the technical subject matter expert for the development and qualification of cell-based methods, ELISAs and qPCR assays for the characterization and testing of recombinant protein drugs. The individual will have demonstrated expertise in the development and application of analytical methods for release and characterization of recombinant biopharmaceutical products.

The candidate will have demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought. This position will contribute to the success of projects in various stages of cross-functional development and tech transfer by designing and planning all analytical aspects of the project, monitoring timeline adherence, reviewing scientific data, writing protocols and reports, representing the Bioassay development group in client interactions and support the management of project deliverables both internally and externally.

The following knowledge, skills, and abilities are required for the successful candidate:

  • Demonstrated ability designing, managing, and executing analytical studies to support the development and cGMP manufacturing of recombinant biopharmaceutical proteins
  • Experience with the development and application of state of the art methods for release and characterization of recombinant biopharmaceutical protein-based products.
  • Ability to comfortably and effectively multi-task in a dynamic and fast-paced environment with defined milestones and deadlines
  • Excellent interpersonal skills including the ability to work as an individual contributor, with internal customers as part of a cross-functional team, and with external clients
  • Ability to apply problem solving skills independently to analytical issues, as well as within the context of cross-functional teams for larger project issues
  • Written communication skills including experience writing protocols, summary reports and test methods
  • Oral communication skills including experience presenting technical project status and data-driven updates to internal and/or external customers.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

·         Responsibilities

  • Plans, conducts, evaluates, interprets, and reports complex laboratory experiments
  • Develops and reviews new bioassay/analytical methods or PD plans
  • Author and Review as appropriate procedures, plans, protocols, or reports
  • Expected to evaluate completeness and accuracy of data collected by other scientists to ensure integrity of research.
  • Accountable for the logical progression of results and interpretation of data.
  • Familiar with new practices and procedures in relevant literatures and is skilled in finding such procedures/practices.

·         Proficiencies

  • The Scientist II has the following proficiencies
  • Has a broad scientific knowledge that can be applied across client projects
  • Demonstrated knowledge of instruments, computer technology, and data analysis required to successfully complete project work and ability to apply knowledge in unusual situations
  • Independent planning, execution, and interpretation of complex laboratory experiments.
  • Understanding of experimental design for analytical or process development
  • Able to review on going experiments to independently solve problems or originate creative solutions to unusual circumstances
  • Understanding of statistical concepts
  • Capable of multi-tasking across different project activities

  • The Scientist II is continuing to develop the following proficiencies
  • Application of advanced scientific knowledge associated with larger and more complex experiments and projects
  • Ability to apply computer systems, instrumentation, and data analysis knowledge to complex situations.
  • A comprehensive knowledge of Excel, Word, and PowerPoint.
  • The design, execution, and interpretation of complex laboratory experiments with broader priorities set by supervisor
  • Performs higher level analyses involving analytical or process experimental design
  • Develop an understanding of cross-functional areas and impact of self's work on these areas
  • Develop an ability to collaborate and communicate across cross-functional areas
  • Interpretation and judgment regarding the quality of experimental outcomes and data to effectively draw conclusions and make recommendations regarding project execution.

·         Supervision

  • Works independently as part of project teams
  • Trains or provides guidance to lower level scientists
  • Typically directs technical work encompassing one aspect of a project
  • Provide project oversight to internal groups with support from manager or technical lead
  • May act as technical lead for smaller to moderate sized programs
  • The individual may functionally supervise the work of junior colleagues with oversight from supervisor ensuring that the goals of the group are met

·         Problem Solving

  • The Scientist II has the following problem solving skills
    • Application of scientific knowledge to the design, planning, and implementation of studies and projects
    • Ability to provide solutions to problems of high complexity
    • Solutions are logical and well supported by literature or data
    • Planning and implementation of new methods and processes
    • Under guidance of direct supervisor may make decisions on technical information generated
    • Understands and works across a range of scientific disciplines to respond to customer needs.
    • Consistently prepares and presents high quality reports and presentations describing scientific information
    • Familiarity and application of available new technologies and vendor offerings
    • Certified LSS Yellow Belt
  • The Scientist II is continuing to develop the following problem solving skills
    • Providing solutions to a wide range of difficult problems
    • Solutions are imaginative, practicable and well-conceived
    • Designs, plans, and implements new methods/technologies and processes to solve project-related problems
    • Under guidance of direct supervisor makes decisions on technical information generated.
    • Possesses an understanding of the research literature associated with own scientific discipline; stays informed of current trends via journals, patents and personal networks of internal and external experts
    • Prepares and presents complex scientific information to internal and external groups
    • Application of LSS problem solving approaches

·         Oral & Written Communication

  • As appropriate, writes and reviews SOPs/STM's/procedures/instructions
  • As appropriate, writes and reviews analytical plans, protocols, or summary reports
  • Authors SME content of technical reports (memos, development reports etc.)
  • Collaborates and communicates across work groups and project teams.
  • Presents at departmental meetings to keep managers and team members apprised of the activities on project.
  • Makes presentations within department and may present outside of department
  • May present papers or posters at scientific meetings
  • Direct communication with clients as SME
  • May communicate with clients on non SME issues with support from manager or technical lead
  • Leader Behaviors
  • Takes responsibility for the consequences of his/her actions and openly admits mistakes and takes actions to correct situations/change behaviors
  • Puts accomplishing the interests of the unit ahead of accomplishing individual goals
  • Draws from disciplines beyond own areas of expertise when solving problems and making decisions
  • Translates feedback into action
  • Actively shares and seeks expertise and best practices across organizational levels/functions
  • Provides guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem
  • Establishes and maintains effective relationships with colleagues and gains their trust and respect.

BACKGROUND REQUIREMENTS:

The position typically requires a MS and 3+ years' experience, BS and 8+ years' experience, and is an entry level position for a PhD degree with 1 – 3 year industry 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. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

 

Company

Company info
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States

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