Instil Bio is looking for a highly motivated and experienced QC Senior analyst/Analyst in the Quality Control organization. Reporting to the Associate Director, Quality Control Analytical, you will be a hands-on resource for team. Initially as part of the start-up activities, you will be responsible for QC laboratory establishment and set-up and performing technical transfer including being trained on all the analytical assays. As the site transitions into operation, you will primarily be responsible for providing technical expertise, troubleshooting, training, and assay execution for analytical testing utilizing flow cytometry, ELISA, PCR, and cell-based bioassay. You will also contribute to the initiation and completion of quality records (i.e. investigation, deviation) associated with analytical testing at the site.
Responsibilities (include but not limited to)
- Provide technical support for assay performance, training and troubleshooting of analytical issues in the context of a GMP laboratory.
- Represent QC as a primary point of contact for analytical methods in collaboration with Manufacturing and Analytical Development organizations.
- Author and revise processes and procedures for analytical method and associated work streams.
- Establish processes and procedures for purchasing, implementation, training and maintaining QC equipment in collaboration with method subject matter experts.
- Coordinate with stakeholders for equipment validation and manage validation activities in alignment with established timelines.
- Responsibility for ensuring electronic data meets Part 11 requirements in alignment with internal procedures.
- Lead teams to support deviations, investigations, CAPAs and change control activities as needed.
- Support inspection readiness activities.
- Participate in generating training module and instruction led training material
- Other duties as required.
- Bachelor Degree with 1-3+ years of experience, preferably in a GMP environment or Master Degree with 0-1+ year of experience, preferably in a GMP environment.
- Experience with flow cytometry, ddPCR, cell-based bioassays, and ELISA methodologies
- Experience in cell therapy is preferred.
- Experience with method qualification and transfer activities.
- Experience in performing equipment validation activities.
- Familiarity with FDA, EU, ICH and GMP guidelines.
- Familiarity with Part 11 requirements.
- Ability to think critically and demonstrate troubleshooting/problem solving skills.
- Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls.
- Excellent skills in Microsoft Office, data analysis software, and other related applications.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Occasional weekends or holiday coverage is required.
- Occasional international travel is required.