What are the responsibilities and job description for the Raw Materials Quality Control Chemist Lead position at FUJIFILM Diosynth Biotechnologies?
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.
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Job Title: Raw Materials Quality Control Chemist Lead
Reports to: Quality Control Chemistry Manager
Summarv: The Raw Materials Quality Control Chemist Lead, with limited supervision, will be responsible for mentoring the team on technical aspects of performing in-process, release and stability testing using the established analytical methods. Following Tech-Transfer Activities, the Lead will be responsible for performing in-process, release and stability testing using the established analytical methods.
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:
- 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 pharmacopeias USP, EP, JP. Experience in assay troubleshooting and problem solving.
Join us! FDB is advancing tomorrow’s 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.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500.
