Process Development Scientist II - Analytical Development

Summary:  

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 analytical and/or virology, and applies knowledge in support of product development and new technologies. The individual should display strong technical knowledge and scientific understanding of the development of analytical and/or virology assays, and DOE studies. The individual may lead a project and assist in multiple projects. The individual is expected to provide strong scientific and technical contributions within the Process Development Group and will work closely with other Departments to develop strong working relationships

External US

Essential Functions:

• Has a broad scientific knowledge that can be applied across client projects
• Assist/lead the development or adaptation and implementation of analytical methods for customer programs.
• Develop, optimize, and transfer methods on multiple client projects and acts as the lead on one smaller client project.
• Demonstrated knowledge of instruments, computer technology, and data analysis required to successfully complete project work and ability to apply knowledge in unusual situations.
• 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.
• Independent planning, execution, and interpretation of complex laboratory experiments.
• Assist or lead some direct interface with external clients to understand their needs and effectively communicate these needs to internal departments.
• Ability to work with team members and client to help troubleshoot and solve complex problems.
• Clearly articulate in presentations to senior management and/or clients regarding problems, updates, and/or results.
• Transfer analytical methods from other collaborators/clients.
• Write SOP/method qualification and validation protocols and reports.
• Maintain a laboratory notebook according to company guidelines.
• Summarize results and generate reports.
• Maintain analytical instrumentation as needed and interface with external vendors for instrument installation and operation qualifications.
• 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.
• Stay abreast of new technologies in the field.
• Expand expertise to other types of assays.
• Ensure lab is maintained (organized, clean, properly supplied).
• All other duties as may be assigned.

Required Skills & Abilities:

• Experience with analytical instrumentation such as analytical chromatography/ELISA.
• Proficiency in assay development.
• Ability to work professionally as part of a team and independently.
• Proficiency with some assays such as ELISA, SDS-PAGE, Western blotting, HPLC, CE, cell-based assays, immunoassays, dd-PCR, and/or molecular assays such as q-PCR.
• Ability to work on multiple projects.
• Experience working in a GMP environment is required.
• Knowledge of statistics for analytical chemistry.
• Ability to formally present problems, updates, and/or results.
• Significant knowledge of bioanalytical techniques demonstrated through industry or academic performance.
• Ability to clearly communicate in writing and verbally to senior management and/or clients.
• Ability to assist in the review of client proposals for accuracy.
• Ability to train technical aspects of the job to analytical personnel.
• As appropriate, writes and reviews SOPs/ procedures/instructions.
• As appropriate, writes and reviews analytical plans, protocols or summary reports.
• Authors SME content of technical reports (memos, development reports etc.).

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.
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
• Ability to lift 50 pounds on occasion and 25 pounds regularly.
• Ability to wear PPE. 
• Attendance is mandatory.

Minimum Qualifications (in addition to required skills and abilities):

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

Preferred Qualifications

• Experience or knowledge of cGMP, QA, and QC for pharmaceutical products.
• Strong hands-on skill in aseptic technique, cell culture, and virology.

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 email FDBTHR@fujifilm.com or call 979-431-3528.