Associate Scientist, Bioassay Development

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 Bioassay Development group at our RTP, NC location is seeking an energetic Associate Scientist to perform sample analysis using bioassay based techniques such as qPCR, ELISA or plate-based potency assays for the characterization and testing of recombinant protein pharmaceuticals. The Associate Scientist’s primary responsibility is the execution and documentation of scientific experiments and maintaining laboratory equipment.  The position assists scientific staff in conducting and reporting the results of laboratory experiments. The individual monitors ongoing experiments for any unusual occurrences. The individual will develop a practical understanding of own scientific discipline and apply this knowledge in support of product development. This position supports the process development and manufacturing organizations with their associated revenue and profit plans as they relate to the on-time delivery of analytical and process development milestones. The individual has a direct impact on work group performance; impact is achieved primarily through personal and team efforts.

The successful candidate requires the following knowledge, skills and abilities:

  • One year of applicable hands on experience in one or more of the following fields: qPCR for residual DNA quantitation, ELISA, cell-based, or plate-based potency
  • Independent use and application of instrumentation and associated software for data acquisition and analysis
  • Basic math and software skills (MS Excel, Word, PowerPoint, Google sheets)
  • Good interpersonal skills, independent drive, willingness to contribute to the success of a team with shared goals, strong problem solving capabilities as well as excellent oral and written communication skills
  • Experience working in a regulated GMP environment is desirable
  • In addition, the successful candidate must be comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Responsibilities

  • Experimental execution of analytical plans/laboratory procedures
  • Document, summarize and report data
  • Maintain laboratory equipment, supplies and work area
  • May support technical transfer into manufacturing or quality control as applicable
  • Be familiar with relevant literature

Proficiencies

The Associate Scientist has the following proficiencies

  • General knowledge of basic chemistry and/or biochemistry and associated techniques
  • Execution of experiments
  • Independent use and application of instrumentation, computer systems and software for data acquisition and analysis
  • Capable of monitoring ongoing experiments for any unusual occurrences
  • An understanding of and application of required techniques in support of projects and studies according to pre-defined plans and protocols

The Associate Scientist is continuing to develop the following proficiencies

  • Advanced knowledge of basic chemistry and/or biochemistry and associated techniques
  • Independent use and application of more complex instrumentation, computer systems and software for data acquisition and analysis
  • Able to assist in designing, conducting, analyzing, data plotting and reporting results of laboratory experiments
  • General knowledge of Excel, Word and PowerPoint
  • Independent planning, execution, and interpretation of routine laboratory experiments
  • Understands and applies required techniques in support of projects and studies according to pre-defined plans and protocols
  • An expanded understanding of instruments, computer technology, and data analysis required to successfully complete project work
  • Ability to monitor on going experiments, may also identify and resolve or suggest solutions to unusual occurrences
  • An understanding of experimental design

Supervision

  • Works under moderate direct supervision

Problem Solving

The Associate Scientist has the following problem solving skills

  • Able to assist in the implementation of new methods and processes
  • Basic equipment troubleshooting

The Associate Scientist is continuing to develop the following problem solving skills

  • Demonstration of practical understanding of own scientific discipline and applies knowledge in support of product development
  • Understanding and application of equipment, technology and materials associated with area of expertise and related studies and projects
  • Ability to work on multiple problems of higher complexity
  • Implementation of new methods and processes
  • Adequately assembles reports and presentations describing scientific information
  • Familiarity with available new technologies and vendor offerings
  • Familiarity with Lean Six Sigma initiatives within company

Oral & Written Communication

  • Prepares summaries of data for technical reports (memos, development reports)
  • As appropriate, writes SOPs/TMs/procedures/instructions
  • As appropriate, writes and reviews analytical plans, protocols or summary reports
  • 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

Leader Behaviors

  • Takes responsibility for the consequences of his/her actions
  • Demonstrates willingness to share roles with others on the team to advance team’s progress as needed
  • Practices attentive and active listening
  • Reviews work to ensure accuracy, completeness, and quality
  • Looks for opportunities for improving work

BACKGROUND REQUIREMENTS:

The position typically requires a BS and 1+ years’ experience or equivalent; an AS and 3+ years’ experience or equivalent, and is an entry level position for a MS degree with no prior experience

The individual should have demonstrated proficiency in the follow areas

  • Capable of using instrumentation to perform general laboratory experiments and document results appropriately
  • Capable of using basic computer systems and software to perform basic data analysis
  • Basic math and software skills (MS Excel, Word, PowerPoint)
  • Be comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines

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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