Associate Principal Scientist, Protein Formulation 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 Associate Principle Scientist independently applies scientific and/or cross-functional knowledge to achieve project goals and provide technical and scientific leadership within the department.  The individual will typically lead customer projects and as expected to complete technical assignments through the self-sufficient design, execution and interpretation of complex experiments. The individual will suggest new areas for development, presents his or her own original ideas and research findings and demonstrate a solid theoretical understanding within their own scientific discipline.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Responsibilities

  • Independently applies scientific and/or cross-functional knowledge to achieve project goals
  • Originates development ideas
  • Identifies and resolves technical project issues
  • Implements strategic departmental research and development goals or ideas
  • Develops and manages departmental work practices
  • Ensures technical quality of work during project execution

Proficiencies

  • The Associate Principal Scientist has 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
    • As appropriate, advanced application of statistical concepts for process design
    • 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
    • Defining and implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards
  • The Associate Principal Scientist is continuing to develop the following proficiencies
    • Provide technical/scientific leadership within department
    • Identification and resolution of complex technical project issues
    • Creative application of chemistry, biochemistry or process knowledge, instrumentation or data analysis to projects and issues
    • Promotion of technical and/or cross functional solutions
    • Design of strategic departmental research and development goals and suggests new areas for development
    • Design and application of new scientific concepts and interprets results for potential application
    • Practical application of MS Project

Supervision

  • A technical resource to colleagues within the department
  • Typically act as departmental technical lead on one or more large program(s) and influences decisions within department
  • Presents his or her own original ideas and research finding
  • Leads cross-functional teams to solve problems or to develop products
  • 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 Associate Principal Scientist has the following problem solving skills
    • Application of scientific knowledge to the design, conduct, and implementation of studies and projects
    • Development and implementation of technical and/or system solutions
    • Creates plans to resolve project related issues
    • Ability to benchmark available technologies relative to other companies or industries
    • Implementation of new technologies within area
    • Contribute strong technical advice to team problem solving
    • Makes decisions on technical information generated
    • Possess a solid understanding of the research literature associated with own scientific discipline; stay 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
    • Makes contributions to LSS based problem solving activities
  • The Associate Principal Scientist is continuing to develop the following problem solving skills
    • Leading others through problem solving or complicated applications involving computer systems, instrumentation and data analysis
    • Benchmarking available technologies relative to other companies or industries
    • Application of advanced scientific concepts to complex problems
    • Published achievements in scientific literature or presentation at conference
    • Interact with management throughout the organization on specific area of expertise
    • Supporting decision making in shaping FFDB research and development agenda
    • Leading the decision-making process during project execution
    • Implementation of new technologies and approaches to solve project-related problems
    • Possesses advanced 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

Oral & Written Communication

  • As appropriate, write, review and approve SOPs/STM’s/procedures/instructions
  • As appropriate, write, review and approve of analytical plans, protocols or summary reports
  • As appropriate, writes reviews and approves departmental and inter-departmental reports for internal and external distribution
  • Serves as an organizational spokesperson on technical issues for a specific area of expertise
  • May support Marketing & Sales activities such as proposal/scope of work review, present on behalf of department at client visits and provide laboratory tours
  • Operates across disciplines to influence scientific decisions
  • Prepares complex proposals and presentations for senior management, including issue identification and resolution
  • A voice on complex scientific and/or technical concepts
  • Develop stature in field of expertise by participation in scientific societies and meetings, review of current scientific literature and timely publications and/or patents
  • Direct communication with clients to communicate technical items and to resolve issues
  • Direct communication with regulatory agencies, industry experts and consultants

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
  • Maintains effective relationships with colleagues across functional units and gains their trust and respect.
  • Understands the impact of actions on project goals
  • Exhibits professionalism and sets an example for others
  • Shares ideas irrespective of functional or work unit lines
  • Actively shares and seeks expertise and best practices across organizational levels/functions
  • Displays high standards of ethical and scientific conduct

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, driving department results and impact is achieved primarily by personal efforts or leading others.
  • The individual is responsible for maintaining project timelines

BACKGROUND REQUIREMENTS:

The position typically requires a PhD and 4+ year experience, MS and 10+ years’ experience or BS and 14+ years’ experience

The individual should have demonstrated proficiency in the follow areas

  • Provide technical leadership for higher level analyses involving analytical or process experimental design
  • Design, execution and interpretation of complex laboratory experiments with broad priorities set by supervisor
  • Application of statistical concepts and performs higher level analyses involving analytical or process experimental design
  • Application of advanced scientific knowledge associated with larger and more complex experiments and projects
  • Interpretation and judgment of the quality of experimental outcomes and data to effectively draw conclusions and make recommendations regarding project execution
  • Defining and implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards

 

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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