Process Development - Associate Scientist - Upstream
The Associate Scientist - Upstream Process Development will assist in the development and execution of experiments for the development, optimization, and characterization of cell-based and viral vaccine processes and will be involved in experimental design, data analysis, and interpretation. This individual will assist the Process and Analytical Development Teams to drive processes towards manufacturing processes for multiple viral projects and provide technical support for associated regulatory filings. The individual should have familiarity with a range of cell-based and viral vaccine production technologies, including cell and virus expansion, infection, scale-up, harvest and filtration technologies.The successful candidate will also be experienced in basic laboratory techniques.
- Assist in the development, optimization, and scale-up of cell- and virus/viral vector-based processes including cell banking, adherent and suspension cell culture, cell counting and metabolite analysis.
- Assist in setting up, operating, and troubleshooting single use stirred tank bioreactors up to 200L scale.
- Assist in maintaining and monitoring process development equipment.
- Operate development and pilot scale upstream equipment, including shake flasks, bench-scale stirred tank bioreactors, with emphasis on single-use equipment.
- Operate various centrifuge and cell/virus culture harvest equipment.
- Participate in developing and carrying out experimental protocols.
- Maintain detailed laboratory notebooks and protocols.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Good laboratory techniques.
- Proficiency with Microsoft Office applications.
- Familiarity with writing SOP's and/or technical documents.
- Awareness of cGMP procedures and protocols.
- Good self-discipline and attention to detail.
- Must have good planning, organizational, and time management skills; excellent oral and written communication skills; and be willing and able to interface with colleagues in many different roles and functions throughout the organization.
- Awareness of scale up and technology transfer from lab scale to pilot scale.
- Knowledge of cell culture including adherent and/or suspension cell growth technologies.
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 (including the required skills & abilities):
- Master's Degree in a science related field; OR
- Bachelor's Degree in a science related field with 1 year of relevant experience; OR
- Associate's Degree in a science related field with 4 years of relevant experience.
- Experience in pharmaceutical or biotechnology industry.
- Degree in Chemistry, Biology, Life Sciences or related field.
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.