QC Lead, Chemistry (College Station, TX)
QC Lead, Chemistry (College Station, TX)
FUJIFILM Diosynth Biotechnologies
United States
See who FUJIFILM Diosynth Biotechnologies has hired for this role
***This is an on-site role at our College Station, TX location. Relocation assistance available.
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.
The 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. This position is a pivotal role to either a technical career path as a Chemist IV or a managerial career path as a Lead for the team, and a successful individual in this role will lead the team regardless of the career path they decide to pursue.
Reports to QC Manager, Chemistry
Work Location College Station, TX
Primary Responsibilities:
- Lead QC analytical testing for GMP in-process, release and stability testing as needed.
PH Conductivity & qPCR.
HPLC, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assay, Peptide Mapping, DNA Sequencing and/or UV/Vis Spectrometry.
Residual Analysis and/or Surfactant Analysis.
Osmolality testing.
Western Blot.
- Executes technical transfer, qualification and validation protocols as needed.
- Leads evaluation of equipment for use.
- Leads IQOQ evaluation.
- Help to maintain safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on a daily basis.
- Technical Writing to include:
Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
Qualification protocols.
Transfer Protocols.
Creating manuals for processes/activities.
Sample plans (support & edit).
Lead the initiation and closure of deviations, CAPAs and Change Controls.
Reviewing methods for accuracy:
HPLC, Chromatography (Ion Exchange, SEC, RP-HPLC, Residual Analytes).
- Lead technical training for less experienced members of the team.
- Facilitate the maintenance and repair of equipment.
- Facilitate the communication between various different departments.
- Develop and support a system for managing test samples, reagents, and reference standards.
- Reviews data obtained for compliance to specifications and reports excursion/out of specifications.
- Leads OOS investigations and support as needed.
- Leads QC support for the sites Environmental Monitoring program and raw material analysis.
- Ensure lab is maintained (organized, clean, properly supplied).
- Perform other duties as assigned.
Qualifications:
- Bachelor's degree preferably in Chemistry or Biochemistry with 4+ years of hands-on laboratory experience.
- Associate's degree preferably in Chemistry or Biochemistry with 6+ years of hands-on laboratory experience.
- 4+ years’ industry experience in a GMP/GxP or a comparable federally regulated environment required.
- Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving.
- 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.
- Excellent written and oral communication skills.
- Excellent organization and analytical skills.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Science and Quality Assurance -
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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See who you knowFeatured Benefits
Inferred from the description for this job
-
Medical insurance -
Vision insurance -
Dental insurance -
401(k) -
Paid maternity leave -
Paid paternity leave -
Tuition assistance
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