R&D Manager - Purification

Overview

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, and 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 both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides 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

We are hiring an R&D Manager- Purification. The R&D Manager- Purification will Coordinate research, development, and manufacturing activities with Sr. R&D Manager. Act as lead to coordinate fermentation batch release for R&D purification, fill-finish, and QC sample scheduling and support production plans within the department function. Support the purification group for the production of the existing RUO product line and the development of new sub-clinical grade recombinant protein products. Develop, optimize, and execute protein clarification and purification experimentation and protocol development for recombinant proteins expressed in bacteria and mammalian cells in a cGMP environment. Responsible for GMP qualification and validation studies to support purification scaling efforts with technology improvements.

External US

Responsibilities:

• Support and assist in managing purification schedules and production
• Conduct manufacturing review for Fermentation and Purification Batch Records
• Conduct manufacturing review for Production Batch Records
• Maintain manufacturing records
• Approve fermentation outputs for release to the purification team using in-process analytics
• Process development scale and pilot scale as required
• Process development and troubleshooting.
• Research and identify means for process improvement and efficiencies
• Research, plan, author, and execute purification technology qualification and validation studies supporting cGMP production of recombinant proteins
• Adhere to product specifications for purity, endotoxin, and identity, bioburden, sterility
• Analyze and interpret data 
• Draft and write SOPs, ,batch record templates and associated documentation
• Present data to the department and project teams
• Assist in managing workflow and prioritization of projects
• Coordinate preventative maintenance schedules with laboratory workflow
• Hands-on training, documentation, and research in the labs

 Required Skills/Education

• Bachelor in Biological/Chemical Science plus 10 years of relevant working experience
• Master’s or Ph.D. in a Biological/Chemical Science plus 5 years of relevant lab-based experience
• Minimum 2 years of relevant industry experience
• Working knowledge of cGMP guidelines for recombinant proteins
• Deep working knowledge of purification design strategies for column-based protein purification
• Formulation methods development for recombinant proteins
• Purification scale-up from milligram to the gram to kilogram quantities of purified product
• Broad technical experience with various protein separation techniques on a small and large scales: affinity, ion exchange, hydrophobic, and size exclusion chromatography
• Expertise in purification column scheme design using size exclusion, hydrophobic/hydrophilic, ion exchange, affinity, and other column chemistries
• 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, bioprocess equipment
• Working in a cGMP environment and authoring GMP qualification and validation project plans
• Up-to-date bioprocessing knowledge with active connections in industry
• 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 perform the 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 encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the 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.