Manufacturing Lead Solution Prep
Manufacturing Lead Solution Prep
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Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track or work towards a supervisory path. Dependent upon assignment the range of technologies may include any of the following:
Company Overview
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what FUJIFILM Diosynth Biotechnologies call Genki.
College Station Texas may be a small university town but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile radius so we are in the center of it all in Texas. And our site is nestled in the hub of innovation representing a source of pride for the area.
Job Description
Upstream Unit:
- SingleUse Cell Culture Vessels/Bioreactors up to 2000L
- Bacterial Fermentation Culture Vessels up to 2000L
- Alpha Wasserman Continuous Flow Centrifuges
- Disposable Magnetic Mixing Bags and Totes
- Cell Expansion and Propagation
- Banking/Cryopreservation of Cell Lines and Viruses
- Hyperstack Cellstack and other Adherent Cell Technologies
- Plate counting microscopic examination
- Monitor cultures take samples turnaround of bioreactor and fermenters sterilization and inoculation
Downstream Unit:
- Medium to Largescale filtration systems including Tangential Flow Filtration (TFF) Hollow Fiber Tangential Flow Filtration (HFTFF) Nanofiltration and depth filtration
- Medium to Largescale Chromatographic systems (KTA).
- PrePacked Columns from 1L to 100L
- Single use mixing systems (Pall & GE)
- Single Use connectivity types such as GE DAC and Colder AseptiQuik
- Bulk filling
- Aseptic process simulation and drug product filling
- Plate counting microscopic examination
- Monitor cultures take samples turnaround of bioreactor and fermenters sterilization and inoculation
Buffer Preparation Unit:
- Preparation of medium from stock raw materials including the compounding mixing testing and filtration for further process needs
- Preparation of buffers from stock raw materials including the compounding mixing testing and filtration for further process needs
- Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures
- Integrity testing of filters
Essential Functions Include:
- Write and review standard operating procedures buffer formulation records and batch production records.
- Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
- Maintain the confidentiality of proprietary company information.
- Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
- Operate general production equipment such as Autoclaves Glass washers Incubators Analytical Scales pH/conductivity meters etc.
- Perform all other duties as assigned.
Technician IV Supervisory Track Option:
- Successfully leads two or more projects at a time.
Required Skills & Abilities:
- Excellent oral and written communication skills interpersonal and organizational skills.
- Proficient with Microsoft Office applications.
- Excellent leadership skills.
- Ability to train others to perform to cGMP standards.
- Good selfdiscipline and attention to detail.
- Must be able to work flexible shifts to include weekend or night shifts and be willing to work outside of normal scheduled hours to meet the demands of the business.
- Excellent math and computer skills.
- Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
- Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.
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 some bending stooping pushing pulling reaching above shoulders and stretching.
- Handeye 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 wear personal protective equipment including safety glasses lab coat safety shoes and gloves.
- Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally.
- Attendance is mandatory.
Technician IV Minimum Qualifications:
- Bachelors degree in Biology Microbiology Chemistry Biochemistry Engineering or related field and 2 years of relevant experience; OR
- Associates degree in Biology Microbiology Chemistry Biochemistry Engineering or related field and 4 years of relevant experience; OR
- High School/GED with 6 years of relevant experience.
Join us! FDB is advancing tomorrows medicine impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves our families our workplace our company our community and the world at large.
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 viaemail 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.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.
Employment Type
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