- Review of QC analytical testing for GMP in-process, release and stability testing as needed:
- pH, Osmolality, Conductivity & qPCR, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assays, Peptide Mapping, DNA Sequencing and/or UV/Vis Spectrometry preferred
- Review technical transfer, qualification and validation protocols as needed.
- Review laboratory logbooks and equipment logbooks
- 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)
- Assisting and initiating closure of deviations, CAPAs and Change Controls
- Reviewing Methods for accuracy:
- HPLC, Chromatography (Ion Exchange, SEC, RP-HPLC, Residual Analytes)
- Reviews data obtained for compliance to specifications and reports excursion/out of specifications
- Provides OOS investigational support as needed.
- Perform other duties as assigned.
Required Skills & Abilities:
- Ability to review raw data, assess assay and system suitability criteria,
- Excellent communication skills.
- Ability to work independently or in a team.
- 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.
- Associates degree preferably in Chemistry, Biochemistry, or a degree in a scientific discipline with 1-2 years of hands on data review experience, and / or laboratory experience in a GMP or GLP environment.
- Familiar with monoclonal antibody and gene therapy testing methodologies.
- Familiar with Empower Software Platform
Salary: Starting salary will be commensurate with education and experience.