Director, Analytical Development
College Station, Texas
- Manages and supervises viral vaccine support and Method Development teams.
- Provides leadership in virally-based contract technology transfer and manufacturing activities (PDVPs).
- Implements ongoing quality improvement processes working with interdepartmental teams.
- Develops and manages Method Development metrics for performance improvement of the team.
- Provides expert guidance to the Method Development team in establishing policies, procedures and strategies that are consistent with cGMP, International guidance and programs.
- Provides leadership and participates in various analytical techniques (e.g., HPLC, ELISA, enzyme activity assays, flow cytometry, bioassays) in support of method development activities.
- Provides leadership and participates in qualifying new lab instrumentation, compile data and documentation of test procedures, and write SOPs, protocols and qualification reports.
- Provides leadership and participates in performing method qualifications and transfer robust and compliant test methods via documented procedures and training of Quality Control, Process Development, and Manufacturing personnel in the execution of the newly developed assays.
- Oversees Method Development Technology Transfer from other collaborators/sites.
- Leads and participates in troubleshooting and implementing new techniques and instrumentation to improve operations.
- Interfaces with external vendors and clients to execute material qualifications and/or method transfers, with emphasis on virally-based vaccine or biotherapeutics.
- Provides leadership role in troubleshooting and solving challenging problems.
- Other duties as assigned.
Required Skills & Abilities:
- Experience in leadership positions in analytical development with emphasis on viral vaccine development; leadership experience in Quality Control a strong plus.
- Ability to set personal performance goals and provide input to departmental objective.
- Significant experience with the influenza vaccine testing and release process, including extensive knowledge of CBER processes, and reagent generation and usage guidelines.
- Experience in applied research and development of virally-based vaccines through early clinical development.
- Ability to support IND-related activities for recombinant vaccines and biotherapeutics, with emphasis on virally-based vaccines.
- Experience with traditional and state of the art analytical instrumentation methods such as analytical chromatography.
- Development of technical solutions to complex problems which require the regular use of ingenuity and creativity.
- A strong attention to detail with a focus on product quality requirements.
- Proven experience in method development, qualification and transfer, along with comfort in a fast-paced work environment.
- Strong computer skills (Microsoft Office products including Excel, Word, Outlook and PowerPoint).
- Experience with statistical analysis techniques and GMP regulations.
- Excellent written and organizational skills.
- Strong organizational and analytical skills.
- Strong interpersonal and leadership skills.
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, walking, bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Attendance is mandatory
- PhD in Virology or Biochemistry (or related field) with a minimum of 6 years of industry experience developing virus-based vaccines and analytical assays.
- MS in Virology or Biochemistry (or related field) with a minimum of 10 years of industry experience developing virus-based vaccines analytical assays.
- At least 10 years of supervisory/management experience.
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.