Process Development - Scientist II - Upstream
The Upstream Process Development Scientist II is responsible for driving the development of new cell culture and fermentation processes at laboratory-scale, manufacturing-scale, technical transfers of client processes into Process Development or Manufacturing, and technical transfers from Process Development to Manufacturing. Projects include, but are not limited to, cell and virus culture, cell banking, fed batch as well as perfusion bioreactor processing, and in-process testing. The individual should display strong technical knowledge and scientific understanding of cell culture, expansion, harvest, medium development, clone selection and development, and DOE studies, as well as having experience in process development with both small and large process scales. The individual may lead a project and assist in multiple projects. The individual is expected to provide strong scientific and technical contributions within the Process Development Group and will work closely with other Departments to develop strong working relationships.
- Develop, optimize, and scale-up bacterial and mammalian cell and virus/viral vector-based processes, including cell banking, adherent and suspension cell cultures in batch, fed-batch, and perfusion modes.
- Generate high quality protocols for studies that include appropriate data capture forms or batch records. Properly close out study documents, perform data integrity and verification on results, perform statistical, analysis and generate and present reports.
- Plan and execute medium development and cell line development studies, perform metabolite/spent medium analyses.
- Assemble, operate, and troubleshoot single-use stirred tank bioreactors from bench scale to 200-L working volume scale.
- Plan and execute various centrifuge and cell/virus culture harvest protocols.
- Support GMP manufacturing through tech transfer, training, and master batch record generation and review.
- Generate scientific reports, including process development reports, and manufacturing summary
- Cross-train in Downstream PD, Virology and Analytical Development groups to gain knowledge and functional capability in these areas.
- Plan, perform and evaluate relevant in-process assays and report results.
- Generate and present oral presentations for peers and senior management, as required.
- Ensure maintenance and monitoring of process development equipment.
- Ability to work effectively in a matrix management environment.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Experience in upstream process development of mammalian, viral, and bacterial cultures and upstream purification of biological products.
- Experience monitoring the performance of laboratory processes and equipment.
- Strong working knowledge of cGMP (current Good Manufacturing Practices).
- Ability to work independently and within a team.
- Ability to provide observations within a developing process.
- Ability to technically lead projects.
- Strong attention to detail.
- Excellent verbal, written and organizational skills.
- Strong computer skills (Microsoft Office products including Excel, Word, Outlook and PowerPoint).
- Strong organizational and analytical skills.
- Strong interpersonal and some leadership skills.
Preferred Skills & Abilities:
- Experience with cGMP operations, manufacturing, QA, QC, and regulatory requirements for pharmaceutical products.
- Experience performing clinical manufacturing.
- Experience in supporting process development and/or GMP manufacturing.
- Experience with single-use bioreactors up to 200-L.
- Strong background in aseptic technique and cell culture.
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 (in addition to required skills & abilities):
- PhD in a science related field; OR
- Master's Degree in a science related field with 4 years of relevant experience; OR
- Bachelor's Degree in a science related field, with 6 years of relevant experience; OR
- Associate's Degree in a science related field and 8 years of relevant experience.
- Experience with cGMP operations, manufacturing, QA, and QC for pharmaceutical products.
- Experience with single-use bioreactors up to 200-L.
- Strong background in aseptic technique, cell culture, and virology.
- Biochemistry, 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 979-431-3500.