- Participate in training the QC Bioassay Staff at FDBT in the established release methods.
- Perform QC analytical testing for GMP release and stability testing as needed.
- Perform ELISA based methods, cell based assays and qualification of critical reagents methodologies.
- Execute tech transfer, qualification, and validation protocols as needed.
- Contribute to writing and revising Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
- Support the establishment of a system for managing test samples, reagents and reference standards.
- Report excursion/out-of-specification results to QC Departmental management.
- Assist in the preparation of technical proposals, amendments, reports and memoranda.
- Provides OOS investigational support as needed.
- Perform other duties as assigned.
Required Skills & Abilities:
- Proficient in ELISA based methods, cell based assays and qualification of critical reagents methodologies.
- Ability to analyze raw data, assess assay and system suitability criteria.
- Perform as a SME in the designated methods transferred into FDBT from FDBU.
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Utilize SDS 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 15 lbs regularly and up to 30 lbs on occasion.
- Attendance is mandatory.
- Master’s degree preferably in Biology or Biochemistry with one (1) year of relevant laboratory experience; OR,
- Bachelor’s degree preferably in Biology or Biochemistry with two (2) years’ of relevant laboratory experience; OR
- Associates degree preferably in Biology or Biochemistry with five (5) years’ of relevant laboratory experience
- AND one (1) year of experience in a GLP/GxP or a comparable federally regulated environment.
- Familiar with monoclonal antibody testing methodology.
- Experience in assay troubleshooting and problem solving.
- Familiar with Quality Systems.