Scientist I - Purification

Overview

We are hiring a Scientist I - Purification. The Scientist I - Purification will develop, optimize, and execute protein purification protocols for recombinant proteins expressed in bacteria and mammalian cells in a cGMP environment. Produce publication quality data for use in company business and regulatory filings. Author and execute methods on AKTA FPLC for automated routine purifications. Experience with chromatography to include ion exchange, hydrophobic interaction, hydroxyapatite, affinity and HPLC. Complete routine sample analysis using HPLC system, SDS-PAGE, and Western Blot for the production of highly purified, biologically active proteins.

FUJIFILM Irvine Scientific, Inc. is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation, reporting to FUJIFILM Holdings Corporation

External US

Responsibilities:

Purification on a developmental scale and pilot scale as required.

Process development and trouble shooting. Research and identify means for process improvement and efficiencies

Adhere to product specifications for purity, endotoxin, and mass

Analyze and interpret data

Hands on training, documentation, and research in the labs

Maintain manufacturing records

Draft and write SOPs, batch record templates and associated documentation

Present data to the department and project teams

Write standard operating procedures, study reports, relevant sections of regulatory filings, and scientific presentations

Education:

B.S. with 2+ years, M.S. with 1+ years of relevant working experience, or Ph.D. with relevant lab/technical experience in Life Sciences, Biochemistry, Cell Biology, Biotechnology, or related protein science

Minimum 2 years of relevant working experience with proteins

Purification Methods Development and scale up from milligram to gram quantities

Broad technical experience with various antibody and protein separation techniques on small and large scale: affinity, ion exchange, hydrophobic, and size exclusion chromatography

Hands-on experience with AKTA FPLC systems such as AKTA Prime, AKTA Explorer, AKTA Pure or similar

Broad experience with analytical protein characterization methods, including HPLC (SEC, IEX), SDS-PAGE, IEF, Nano UV-Vis spectrophotometer, Western-blot

Working in a cGMP environment

Ability to work as a team player with a positive attitude

Ability to multi-task, attentive to details, and working within a compliance-driven department

Ability to speak, write and read English fluently

Good oral and written communication skills

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 per essential functions.

While performing the duties of this job, the employee is frequently required to stand. The employee is occasionally required to walk, sit, use hands to handle, feel or reach with hands and arms, climb or balance, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds

Specific vision abilities required by this job include close vision and depth perception

Must be capable of a minimal amount of air travel

WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Employee must be familiar with, implement and observe the SOPs related to working in the laboratory and manufacturing environments

Laboratory environments frequently require wearing provided eye protection and lab coats

The employee may be required to enter manufacturing areas where higher noise levels may necessitate wearing provided ear and eye protection

Controlled environments in manufacturing may require wearing provided head covering, gloves, and lab coats or clean room garments. Additionally, respiratory protection may be required in powder manufacturing areas

Scientific research projects may require occasional weekend work.

EEO/COVID/AGENCY NOTES

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms’/employment agencies to any employee at Fujifilm via-email, the internet, or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms’/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.