Director - Analytical Development
For over 30 years, FUJIFILM Diosynth Biotechnology's mission has been advancing tomorrow's medicine. As a global CDMO, we work in partnership with the most innovative biopharma and biotech companies across the world who are reimagining healthcare's potential. We help to accelerate their progress, expand their capabilities, streamline their processes, and strengthen their innovation. So when our customers' potential cures, vaccines, biologics, and accomplishments make strides – or even become new realities for patients – we know our work, our manufacturing expertise, and our partnership helped make it happen.
FDB is a place of passion – a place of what we call Genki. Where diverse perspectives and people come to life. Where opportunity for growth has no end. Where passion is followed, discovered, and nurtured. Where the energy is undeniable, enthusiasm is pervasive, and drive is infectious.
Our site is dedicated to cutting-edge areas like gene therapy and vaccine development, such as COVID-19, and continuously growing into new capabilities and fields. The work here has a start-up feel, as it is dynamic and ever-changing. The challenges we work on across end-to-end manufacturing help advance our partners' possibilities forward.
The Director of Analytical Development is responsible for providing technical leadership in the area of virus-related vaccine and biotherapeutic technology transfer, development and in analytical methods development. This individual will help deliver virally-based capability for current and future clients.
- 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.