Overview

Summary: 

The Scientist II independently designs, executes and interprets complex laboratory experiments and development activities with priorities set by supervisor/project lead to achieve project goals. The individual should display good technical knowledge and scientific understanding of downstream purification of viruses, proteins, and plasmid DNA as well as having knowledge of process development at both small and large process scales.

Internal Job Description

Essential Functions:

• Take a leading role in the development, planning, optimization, and scale-up of Downstream Processes.

• May act as technical lead for smaller to moderate sized programs.
• Demonstrated expertise in the operation of downstream processing equipment; chromatography, UFDF, depth filtration etc.
• Independent planning, execution, and interpretation of complex laboratory experiments.
• Understanding of experimental design for process development.
• Able to review ongoing experiments to independently solve problems or originate creative solutions to unusual circumstances.
• Capable of multi-tasking across different project activities.
• Support tech transfer in to manufacturing as applicable.
• Expected to evaluate completeness and accuracy of data collected by other scientists to ensure integrity of data.

• Maintains a detailed laboratory note book in line with FDBT policies.

• Familiar with new practices and procedures in relevant literatures and is skilled in finding such procedures/practices .
• Perform all other duties as assigned.

Knowledge/Technical Expertise

Individual will have broad knowledge/expertise relevant to downstream processing of protein, virus, and plasmid DNA based products expressed in mammalian, bacterial, insect and yeast cells. Knowledge/expertise should be practical and focused on lab-related activities:

• Downstream development of purification processes.
• Demonstrated hands on experience with chromatography based processing methods and tangential flow filtration techniques.
• Experience with GE Healthcare’s AKTA line of chromatography systems or similar systems.
• Protein biochemistry (protein folding, protein degradation, aggregation, etc.).
• Broad Scientific knowledge that can be applied across client programs.
• Independent planning, execution, and interpretation of complex laboratory experiments. 
• Independent use and application of more complex instrumentation, computer systems and software for data acquisition and analysis.
• Understands statistical concepts.
• Able to monitor on going experiments and identify and resolve or suggest alternates or solutions to complex occurrences.
• Instrument care, maintenance, and data interpretation.
• Document writing, data interpretation, presentation, statistical analysis and trending.
• Knowledge of cGMP concepts.

Required Skills & Abilities:

• 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.
• 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.

• 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.
• Prepares written summaries of data for technical reports (memos, development reports, client updates).
• As appropriate, writes SOPs/STM’s/procedures/instructions.
• The individual may functionally supervise the work of junior colleagues with oversight from supervisor ensuring that the goals of the group are met.
• 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
• The ability to work in team oriented environment is essential, as this person will work closely with other members of the Process Development Group and participate on multidisciplinary project teams.
• General knowledge of Excel, Word and PowerPoint.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, along with some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Attendance is mandatory.

Minimum Qualifications:

• Master’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with four (4) years’ of relevant experience; OR
• Bachelor’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with six (6) years’ of relevant experience; OR
• Associates Degree preferably in Chemistry, Biology, Life Sciences or related field, with eight (8) years’ of relevant experience.

Preferred Qualifications:

• Experience in pharmaceutical or biotechnology industry.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.