Scientist II, Downstream Process 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 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

 

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Responsibilities

  • Plans, conducts, evaluates, interprets and reports complex laboratory experiments
  • Develops and reviews new analytical methods or PD plans
  • Reviews 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

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
  • 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.

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 significant impact on work group performance and helps drive work group results. The individual may be responsible for maintaining project timelines

 

BACKGROUND REQUIREMENTS:.

The position typically requires a MS and 3+ years’ experience, BS and 7+ years’ experience and is an entry level position for a PhD degree with no prior experience

The individual should have demonstrated proficiency in the follow areas

  • Advanced knowledge of chemistry and/or biochemistry and associated techniques
  • Independent planning, execution and interpretation of routine and non-routine laboratory experiments. `
  • General knowledge of Excel, Word and PowerPoint.
  • Have acquired broad scientific knowledge within their own scientific discipline and applies best practices to client projects.
  • An understanding of instruments, computer technology, and data analysis required to successfully complete project work.
  • Ability to monitor on going experiments and suggest alternates or solutions to unusual occurrences.

 

 

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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