Process Development - Senior Scientist - Analytical Development

Summary:  

The Senior Scientist in the Analytical Development, Cell based assay Group is primarily involved in the development, establishment, qualification and validation of cell-based analytical methods. The Senior Scientist is responsible for designing, planning, executing and interpreting complex laboratory experiments and development activities within established timelines.

The Senior Scientist in the Cell based assay group is also responsible for creating method qualification/validation protocols and summary reports, executing protocols, reviewing data, ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshooting issues/spearheading investigations and working closely with the QC group and client.

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

External US

Essential Functions:

• Develop, optimize, and implement cell-based analytical methods for customer and internal programs.
• Design and execute method transfers/qualifications/validations of cell-based analytical methods based on regulatory guidelines and industry best practices.
• Act as technical lead for client programs and 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.
• Evaluate methods for cGMP readiness and perform gap analyses.
• Interface with other groups to drive project success, including Analytical Development, Project Management, Quality Control and Quality Assurance.
• Troubleshoot method challenges in a creative and controlled manner.
• Provides expertise and training to junior scientists.
• All other duties as may be assigned.

Knowledge/Technical Expertise:

• Hands on experience of technical aspects such as culture of adherent and suspension cells, infectious viral titer assays (plaque assay, focus forming assay, TCID₅₀), FACS, cell proliferation assays, cell death and survival assays.
• Good understanding of virology and viral titer assays.

• Experience in developing and optimizing assays.

• Proficient in molecular biology techniques such as ELISA, SDS-PAGE, Western blotting, qPCR or ddPCR.

• 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.

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
• 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 Excel, Word and PowerPoint.

Supervisory Responsibility:

• Carries out supervisory responsibilities in accordance with company policies and applicable laws including interviewing, hiring, planning, assigning, directing work, training and development, disciplinary actions, performance reviews, addressing complaints and resolving problems.

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 Virology, Biology, Life Sciences or related field with at least three (3) years of relevant experience; OR
• Master's Degree in Virology, Biology, Life Sciences or related field with six (6) years of relevant experience; OR
• Bachelor's Degree in Virology, Biology, Life Sciences or related field, with eight (8) years of relevant experience

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.