- 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.
- Executes tech transfer, qualification and validation protocols as needed.
- Contributes to writing and revising Standard Operating Procedures (SOPs), Technical Reports, and other Good Manufacturing Practices (GMP) documentation as appropriate.
- Maintain data integrity and compliance with company SOPs and specifications, FDA, and cGMP regulations.
- Participate in functions involving teams which impact timelines, improve quality and increase efficiency.
- Complete all testing, including special project/protocol testing in a timely and appropriate manner.
- Must communicate effectively (verbal and written) with supervisors and peers and be able to work cross-functionally with other groups.
- 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.
- Strong critical thinking, time management and organizational skills. Demonstrate the ability to multitask and consistently meet deadlines.
- 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.
- Attendance is mandatory.
- Master’s degree in science related field with two (2) years of experience; OR
- Bachelor’s degree in science related field with four (4) years of experience; OR
- Associate’s degree in science related field with six (6) years of experience.
- At least 2 years’ industry experience in a GMP / GxP or a comparable federally regulated environment.
- Degree in Biology.
- Familiar with monoclonal antibody testing methodology.
- Experience in assay troubleshooting and problem solving.
- Familiar with GMP documentation and Quality Systems.