- Perform QC analytical testing for GMP release and stability testing as needed.
- pH Conductivity & qPCR required
- HPLC, Agarose Gel Electrophoresis, UPLC, CE, IEF and/or UV/Vis Spectrometry preferred
- Osmolality testing
- SDS Page & Western Blot
- Executes technical transfer, qualification and validation protocols as needed.
- Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
- Develop and support a system for managing test samples, reagents and reference standards.
- Reports excursion/out of specifications results to the QC Departmental Supervisor/Manager.
- Provides OOS investigational support as needed.
- Ensure lab is maintained (organized, clean, properly supplied).
- Perform other duties as assigned.
Required Skills & Abilities:
- Ability to analyze raw data, assess assay and system suitability criteria.
- Perform as a SME in the designated methods transferred into FDBT.
- 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.
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 hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
- Ability to lift up to 30 pounds on occasion.
- Attendance is mandatory.
- Master’s degree in Chemistry, Biochemistry or related degree with 1 year hands on laboratory experience; OR
- Bachelor’s degree in Chemistry, Biochemistry or related degree with 2 years hands on laboratory experience.
- AND 2 years of experience in a GMP/GxP or a comparable federally regulated environment.
- Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving.