Raw Materials Quality Control Chemist Lead

Overview:

The work we do at FDB 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 FDB 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.

External US:

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.

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 hand-eye 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 off-shift hours, as needed to support manufacturing activities.

• Must be willing to travel occasionally, as needed.

• Attendance is mandatory.

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 ~~~ or call ~~~.

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.