Process Development - Scientist I - AUC Method Development

Summary:  

The Scientist I in the Analytical Development (VAD) is primarily involved in the development, establishment, qualification, and validation of analytical ultracentrifugation (AUC) and analytical methods. The Scientist I is responsible for planning, designing, executing, and interpreting complex laboratory AUC and analytical experiments and development activities within established timelines with broad priorities set by AD leadership to achieve project goals.

The key individual will be responsible for characterization and testing of viral vector-based gene therapy products, and recombinant protein therapeutics through analytical ultracentrifugation (AUC) as well as perform a suite of analytical and biophysical assays to accommodate rapidly changing priorities while delivering high-quality results. Troubleshoot issues/spearhead the investigations and work closely with Process Development groups and clients.

The individual should possess broad scientific knowledge of bioanalytical techniques and cell culture that are used to characterize viruses and proteins as well as strong communication and technical writing skills. The individual will lead internal and client-based projects, stay abreast of new technologies, regulatory requirements, and quality standards related to the area of analytical method development with AUC centric. The candidate will be expected to follow good cGMP, lab, and documentation practices.

External US

Essential Functions:

• Plan experimental design, develop, draft SOPs, execute, and optimize analytical ultracentrifugation (AUC), analytical, and biophysical methods for customers and internal programs.
• Characterize viral vectors and recombinant protein therapeutics, and sample testing through AUC.
• Execute routine analytical sample testing through ELISA, qPCR, ddPCR, soloVPE, spectroscopy, biophysical characterization like Capillary Electrophoresis (CE), SDS-PAGE, Western Blot to support process development.
• Design and execute method transfers/qualifications of analytical methods based on regulatory guidelines and industry best practices.
• Generate, manage, analyze, and evaluate critical data in a highly organized manner and deliver high quality results verbally, in notes, reports, and presentations. Should be able to exercise technical judgment in the design, execution, and interpretation of experiments.
• Act as technical lead, provide updates and professional recommendations to external customers.
• Lead interactions with external customers to understand their needs and effectively communicate these needs to internal departments.
• Maintain a thorough understanding of project timelines and milestones, and openly communicate scheduling challenges.
• Plan and execute laboratory work for self and junior members of team based on customer milestones and Department performance standards and metrics.
• Prepare and/or review technical documents such as protocols, reports, test methods, summary slides and standard operating procedures.
• Review data within the team, deliver results verbally, in presentation, notes, and reports.
• Authors subject matter expert (SME) content of technical reports (memos, development reports etc.)
• Interface with other groups to drive project success, including Analytical Development, Analytical Method Transfer, Cell Based, Quality Control, Upstream and Downstream Process Development, and Project Management.
• Troubleshoot method challenges in a creative and controlled manner.
• Provides expertise and training to junior scientists.
• All other duties as may be assigned.

Required Knowledge/Technical Expertise:

• Hands-on expertise or experience with analytical ultracentrifugation (AUC) with SEDFIT or Ultrascan software.
• Experience working with BECKMAN COULTER Optima AUC-Absorbance/Interference Optics with An-50 Ti Rotor.
• Experience with AUC sample preparation, experiment design, data capture, and analysis.
• Proficient in molecular biology techniques such as ELISA, PCR, qPCR or ddPCR, soloVPE, spectroscopy, capillary electrophoresis (CE), SDS-PAGE, Western blot, HPLC/UPLC, and chromatography – preferred but not required
• Good understanding of analytical, virology assays.
• Experience in developing and optimizing assays.
• Understanding of data analysis tools and relevant statistical methods.
• Demonstrated ability to professionally relay analytical data and conclusions both visually and verbally.
• Experience working in a cGMP environment is preferred but not required.

Required Skills & Abilities:

• Builds credibility within the group by performing high quality work and identifying opportunities to improve workflow.
• Ability to operate efficiently and productively with minimal supervision.
• Strong oral and written communication skills. Ability to multitask.
• Good interpersonal skills and the ability to work both individually or as part of a team.
• Strong problem-solving and troubleshooting skills.
• Comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines.
• Comprehensive knowledge of Microsoft Office suite like Microsoft Word, Excel, PowerPoint, OneNote, Outlook and scientific software's like GraphPad/Prism 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, office and laboratory equipment's and pipettes.
• 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 personal protective equipment (PPE).
• Onsite attendance is mandatory.

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

• Master's Degree in Analytical Sciences, Biochemistry, Biology, Chemistry, Life Sciences, or related field, with relevant experience or AUC expertise; OR
• Bachelor's Degree in Analytical Sciences, Biochemistry, Biology, Chemistry, Life Sciences, or related field, with four (4) years of relevant experience or AUC expertise 

Preferred Qualifications

• Experience in pharmaceutical or biotechnology industry is preferred but not required.
• Experience working in a contract manufacturing or testing organization is preferred but not required.

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 979-431-3500.

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