- Execute method transfers/qualifications/validations based on regulatory guidelines and industry best practices.
- Perform assays to evaluate the accuracy, precision, specificity, linearity, robustness, and detection/quantitation limits of analytical methods.
- Maintain laboratory instrumentation and assist with vendor qualifications.
- Develop expertise on a subset of analytical methods and participate in method troubleshooting activities.
- Maintain awareness of project timelines and milestones and openly communicate scheduling challenges.
- Assist in the preparation of technical documents including protocols and reports.
- Finalize analytical test methods; route documents for approval within MasterControl.
- Interface with other groups to drive project success, including Analytical Development, Project Management, Quality Control, and Quality Assurance.
- Provide assistance and training to other scientists/analyst within Process Development and Quality Control since QC does not have scientists.
- Champion the success and continuous improvement of the group.
- Performs other duties as assigned.
The ideal candidate will have knowledge and expertise relevant to viral and protein analytics and protocol-based method evaluations.
- Some hands on experience in the following technical fields: HPLC/UPLC, electrophoresis, spectroscopy, plate-based assays, PCR (including quantitative and droplet digital), viral titer assays.
- Knowledge of CFR 21 part 11 compliant software packages (such as Empower, SoftMax Pro).
- Knowledge of cGMP regulations.
- Understanding of data analysis tools and relevant statistical methods.
- Demonstrated ability to professionally relay analytical data and conclusions both visually and verbally.
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.
- Demonstrated problem solving capabilities for standard biopharmaceutical laboratory techniques.
- Comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines.
- Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint.
This position will not have direct reports.
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 sitting/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.
- Master’s Degree preferably in Chemistry, Biology, Life Sciences or related field; OR
- Bachelor’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with one (1) year of relevant experience; OR
- Associate’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with 4 years of relevant experience.
- Experience in pharmaceutical or biotechnology industry.
- Experience working in a contract manufacturing or testing organization is preferred.
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.