QC Lead, Chemistry (College Station, TX)

***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.