- Develop scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable bioreactors in the laboratory setting for the production of viral vectors.
- Provides in plant support for cGMP manufacturing of preclinical and clinical materials.
- Set-up, operate, and troubleshoot single use stirred tank bioreactors up to 200L scale.
- Carry out upstream process research and development on a variety of microbial and cell culture derived biopharmaceuticals including MAbs, Immunoglobulins, vaccines (e.g. pDNA & viral), etc.
- Assist in achieving high yielding cGMP biopharmaceutical production through clone selection, media and feed development, seed train optimization, bioreactor process scale-up, clone stability testing and effective transfer to manufacturing.
- Lead projects to develop and optimize analytical methods for product quality assessment.
- Maintain and monitor process development equipment. Propose modifications to processes or equipment to deliver improvements.
- Support analytical evaluation, interpret data and work with other team members to integrate results into overall process development plans.
- Generate, manage and evaluate critical data and records of all upstream process development operations in support of regulatory requirements.
- Collaborate and coordinate with colleagues as necessary to facilitate in technology transfer of processes, e.g., Downstream, QA, QC, etc.
- Develop and provide technical reports, data analysis, SOP’s, and investigate and complete deviations as need.
- Evaluate and implement new technologies for upstream process development.
- All other duties as required.
Required Skills & Abilities:
- Hands on experience with mammalian and/or insect cell culture, aseptic techniques.
- Proven experience in the scale up and technology transfer from pilot plant to commercial scale
- Cell culture protocol experience using HYPERStack vessels.
- Proven experience using Icellis bioreactors and Triton CF 10 cell culture vessels.
- Proven experience in adherent and suspension cell culture lines.
- Excellent organizational, interpersonal, analytical skills, and problem solving skills.
- Experience/familiarity with cell culture and cell based assays is required.
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.
- PhD preferably in Biochemistry, Chemistry, Biology, Engineering or related field with 2 years relevant industry experience; OR
- Master’s Degree preferably in Biochemistry, Chemistry, Biology, Engineering, or related field with 6 years relevant industry experience.
- Hands-on upstream process transfer experience.
- Experience working in a cGMP facility.
- Technical Project 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.