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Senior Scientist, Downstream Process Development

Research Triangle Park, North Carolina

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

The Senior Scientist designs, executes and interprets complex laboratory experiments and development activities with broad priorities set by supervisor to achieve project goals. The individual demonstrates an application of scientific knowledge to the design, conduct, and implementation of studies and projects and possesses a solid theoretical understanding within their own scientific discipline.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Responsibilities

  • Originates development ideas
  • Independently applies scientific knowledge to achieve project goals
  • Individual draws conclusions from scientific findings and applies these findings to the project.
  • Suggests new innovative ideas and technologies
  • Presents his or her own original ideas and development findings

Proficiencies

  • The Senior Scientist has the following proficiencies
    • Able to apply computer systems, instrumentation and data analysis knowledge to complex situations
    • Comprehensive knowledge of MS Excel, Word and PowerPoint
    • Designs, executes and interprets complex laboratory experiments with broad priorities set by supervisor
    • Application of statistical concepts and performs higher level analyses involving analytical or process experimental design
    • Applies advanced scientific knowledge associated with larger and more complex experiments and projects
    • Interprets and judges the quality of experimental outcomes and data to effectively draw conclusions and make recommendations regarding project execution
    • Demonstrated ability to multi-task across different project activities
  • The Senior Scientist is continuing to develop the following proficiencies
    • Ability to complete technical assignments by designing, executing and interpreting complex experiments
    • Provide technical leadership for higher level analyses involving analytical or process experimental design
    • Initiate new experimental approaches and related work processes and procedures that align with company and regulatory requirements
    • Partner across company functions and collaborates effectively with respect to identifying and addressing problems and opportunities that affect or require input from multiple units within the company
    • General knowledge of MS Project

Supervision

  • Works independently with minimal guidance
  • Train and provides guidance to lower level scientists
  • The Senior Scientist may be assigned as a technical lead on smaller to moderate programs and may be a technical lead on larger programs as appropriate with over sight
  • Takes ownership as SME for a specific area or technology within functional group
  • The individual may functionally supervise or provide direction for junior colleagues providing ongoing coaching and feedback and may include providing input to supervisor regarding performance reviews and ensuring that the goals of the group are met.

Problem Solving

  • The Senior Scientist has the following problem solving skills
    • Applies scientific knowledge to the design, conduct, and implementation of studies and projects
    • Provides 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
    • Consistently prepares and presents complex scientific information to internal and external groups
    • As required, participates in LSS based problem solving
  • The Senior Scientist is continuing to develop the following problem solving skills
    • Development and implementation of technical and/or system solutions
    • Creates plans to resolve project related issues
    • Effectively benchmarks available technologies relative to other companies or industries
    • Implementation of new technologies within area
    • Contributes strong technical advice to team problem solving
    • Makes decisions on technical information generated
    • Application of LSS practices

Oral & Written Communication

  • As appropriate, writes and reviews SOPs/STM’s/procedures/instructions
  • As appropriate, writes and reviews analytical plans, protocols or summary reports
  • As appropriate, writes reviews and approves departmental reports for internal and/or external distribution
  • Writes and reviews departmental technical reports (memos, development reports etc.) containing cross-discipline information
  • May approve reports for external distribution when acting as project technical lead
  • Makes presentations within department and may present outside of department
  • Present papers or posters at scientific meetings
  • Establishes cross-functional communication within FFDB
  • Direct communication with clients to communicate technical items and to resolve issue

Project Technical Leadership

  • If the individual is assigned as a Technical Lead of a client project, these activities and responsibilities apply
  • Maintain project timelines
  • Responsible for communicating project milestones to project staff
  • Responsible for writing project plan and experimental execution schedule to meet project timelines
  • As appropriate, responsible for documentation for tech transfer to manufacturing or method qualification with QC
  • Responsible for experimental design and planning experimental execution
  • Responsible for ensuring lab equipment is setup for new program and implementing new technology needed for project execution
  • Responsible for regular interaction with technical operations, manufacturing, QA or QC (as appropriate) to ensure successful process transfer
  • Troubleshoot and resolve technical issues during development and transfer/scale-up to manufacturing or QC
  • Ensure that project documentation follows R+D documentation practices
  • Mentor junior staff on the project and planning junior staff activities for successful experimental execution
  • Provide tier board updates as appropriate
  • Serve as the primary liaison for the functional department to the client and internal customers
  • Represent the functional department at internal meetings
  • Responsible for providing written technical updates to the client and internal customers
  • Creates plans to resolve project related issues
  • Engage senior management in a timely manner when project issues or problems arise
  • Provide monthly project reports to department head summarizing milestones, successes and issues
  • Provide project updates as appropriate to CPL

Leader Behaviors

  • Takes responsibility for the consequences of his/her actions and openly admits mistakes and takes actions to correct situations/change behaviors
  • Openly shares information, knowledge and expertise with co-workers
  • Draws from disciplines beyond own areas of expertise when solving problems and making decisions
  • Seeks opportunities for multi-disciplinary experiences and/or assignments outside comfort zone for personal development
  • Researches how other teams have approached similar projects
  • Maintains effective relationships with colleagues across functional units and gains their trust and respect.
  • Provides guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem

SCOPE MEASURES:

  • 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 department performance and impact is achieved primarily by contributing to team efforts. The individual may be responsible for maintaining project timelines

BACKGROUND REQUIREMENTS:

The position typically requires a PhD and 1+ year experience, MS and 6+ years’ experience or BS and 10+ years’ experience.

Knowledge of protein purification is essential, including techniques such as ion exchange chromatography, hydrophobic chromatography, mixed mode chromatography, precipitation, filtration and tangential flow filtration. Experience in process development in GMP purification processes is also required.

The individual should have demonstrated proficiency in the follow areas

  • Independent planning, execution and interpretation of complex laboratory experiments
  • Demonstrated execution of experimental design for analytical or process development
  • Have acquired broad scientific knowledge within their own scientific discipline and applies best practices to client projects
  • Demonstrated knowledge of instruments, computer technology, and data analysis required to successfully complete project work.
  • Ability to independently solve problems or originate creative solutions to complex circumstances

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 identity or any other protected class.

 

 

 

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