Quality Control Raw Materials Chemist III

Position Overview

The Quality Control Raw Materials Chemist III, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. Following Tech-Transfer Activities, the candidate will be responsible for performing in-process, release and stability testing using the established analytical methods.

 

Job Title: Quality Control Raw Materials Chemist III

Reports to: Quality Control Chemistry Manager

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s 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 small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile 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

Primary Responsibilities:

• 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.
• Provides OOS investigational support as needed.

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 designated methods transferred into FDBT.
• Previous pipetting experience.
• 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:

• Bachelor's degree in Chemistry, Biochemistry, or related degree with three (3) years hands-on laboratory experience; OR
• Associates degree in Chemistry, Biochemistry, or related degree with five (5) years of hands-on laboratory experience;
• AND 2 years' industry experience in a GMP / GxP or a comparable federally regulated environment.

 

Preferred Qualifications:

• Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving

 

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 requ