The Quality Control Cell Biology Lead, with limited supervision, will be responsible for overseeing day to day operations of the QC Cell Biology Group. This position will involve handing out daily assignments, ensuring assignments are completed within the given time period, and reviewing data. The Quality Control Cell Biology Lead will also participate in Project Team Meetings. The successful candidate will assist in Method Qualifications, Technology Transfer of established methods, and performing in-process, release and stability testing as needed.
- Oversee day to day activities of the Cell Biology
- Mentor junior analysts in conducting analytical testing, equipment troubleshooting, and Good Documentation Practices (GDP)
- Responsible for reviewing data generated by the QC Cell Biology
- Oversee equipment PM and calibrations to ensure the laboratory maintains GMP compliancy.
- Responsible for Equipment logbook review as needed.
- Perform QC analytical testing for GMP in-process, release and stability testing as needed
- Executes technical transfer, qualification and validation protocols as needed.
- Technical Writing to include
- Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
- Writes, reviews, approves Qualification protocols
- Writes, reviews, approves Transfer Protocols
- Creating manuals for processes/activities
- Review and edit Sample Plans
- Author Product Specifications
- Assisting and initiating closure of deviations, CAPAs and Change Controls
- Reviewing Methods for accuracy
- Develop and support a system for managing test samples, reagents and reference standards.
- Reports excursion/out of specifications.
- Leads OOS investigations as needed.
- Perform other duties as assigned.
Required Skills & Abilities
- Ability to analyze raw data, assess assay and system suitability criteria, understand process from beginning to end.
- Excellent communication skills.
- Ability to work independently or in a team.
- Perform as a SME in the designated methods transferred into FDBT.
- 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 30 pounds on occasion.
- Attendance is mandatory.
- Master's degree preferably in Biology with 4 years hands on laboratory experience; OR
- Bachelor's degree preferably in Biology with 8 years hands on laboratory experience.
- Minimum of 1 year serving a team leader/ cell biology in a GMP Environment
- Familiar with both monoclonal antibody and gene therapy testing methodologies. Experienced in assay troubleshooting and problem solving.
Salary Starting salary will be commensurate with education and experience.