Raw Materials Quality Control Chemist Lead

The Raw Materials Quality Control Chemist Lead with limited supervision will be responsible for mentoring the team on technical aspects of performing inprocess release and stability testing using the established analytical methods. Following TechTransfer Activities the Lead will be responsible for performing inprocess release and stability testing using the established analytical methods.

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.

Essential Functions:

• Lead QC analytical testing for raw material testing as needed.
• Function as SME for raw material release and chemical analysis of materials.
• Collaborate and/or approve item specifications.
• Assist with scheduling and coordination of raw materials sample testing and release.
• Assist with outsource lab testing audits; follow up for data and results reconciliation.
• Assist with training and technical mentoring for technicians with less experience.
• Prepare monthly metrics for raw material release.
• Maintain adequate inventory of supplies needed for all raw material sampling including but not limited to pipets containers and consumables.
• Perform area cleaning and waste removal as needed.
• Author review and update SOPs as needed; understand and follow complex written procedures
• Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in Deviations and recommend possible corrective actions.
• Maintain the safety and orderliness of the Retain Cage.
• Reports excursion/out of specifications results to the QC Departmental Supervisor/Manager.
• Lead OOS investigations and support as needed.
• Initiate and manage Change Controls and CAPAs
• Lead technical training for less experienced members of the team.
• Perform other duties as assigned.

Required Skills & Abilities:

• Ability to analyze raw data assess assay and system suitability criteria understand process from beginning to end and explain process.
• Excellent communication skills.
• Ability to work independently or in a team.
• Perform as a SME in the sampling and release of Raw Materials.
• Experience with the pharmacopeias.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Utilize MSDS sheets to properly assess chemical hazards spill response procedures and PPE requirements if indicated.
• Excellent attention to detail.
• Computer proficiency required
• Excellent written and oral communication skills.
• Excellent organization and analytical skills.

Minimum Qualifications:

• Bachelors degree in Chemistry Biochemistry or related degree with three 3 years handson laboratory experience; OR
• Associates degree in Chemistry Biochemistry or related degree with five 5 years of handson laboratory experience.
• AND 2 years industry experience in a GMP / GxP or a comparable federally regulated environment.

Preferred Qualifications:

• Familiar with pharmacopeias USP EP JP. Experience in assay troubleshooting and problem solving.

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 and stretching.
• Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals gases fumes odors dusts and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses lab coat gloves specialized clothing including laboratory scrubs (pants and shirt) cleanroom (ISO 8 to ISO 5 gowning material and appropriate shoes required in most areas associated with this position.
• Must be willing to work flexible hours.
• Ability to lift up to 15 lbs regularly and up to 30 lbs on occasion.
• Ability to work weekends and offshift hours as needed to support manufacturing activities.
• Must be willing to travel occasionally as needed.
• Attendance is mandatory.

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.

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.

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.