The Fujifilm Diosynth Biotechnologies, USA Analytical Development group is seeking a skilled scientist to fill an exciting technical leadership role as Senior Scientist located at the Bioprocess Innovation Center in Morrisville, North Carolina.
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 successful candidate will lead matrix team execution of client-based projects within the Analytical Development group. 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 analytical development group in client interactions and managing project deliverables 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. The successful candidate must have extensive experience with at least two of the following: liquid chromatography (HPLC/UPLC), capillary electrophoresis, isoelectric focusing, and mass spectrometry
- 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.
The following knowledge, skills, and abilities are desired for the successful candidate:
- Experience working in or interfacing with a regulated GMP environment is desirable
- Experience managing scientists in a direct or matrix environment
- Experience working in a contract manufacturing or testing organization is preferred (demonstrated ability to work with clients)
MAJOR ACTIVITIES AND 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.
- 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
- 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
- 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.
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
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.