Instil Bio is seeking a driven and experienced Sr. Analyst/Group Lead – Raw Materials in the Quality Control organization. The successful candidate will develop, implement, and maintain the raw material program and internal procedures and processes in compliance with regulatory requirements and commitments for clinical and commercial products. The individual will work closely with a cross-functional team (e.g. Manufacturing, Quality Assurance, Supply Chain, etc.), as well as internal and external laboratories to ensure testing completion including review and approval of the results.
The candidates must be knowledgeable of raw material processes, GMPs, regulations, quality lab investigations. This role will comprise multiple critical functions:
In this role, the Sr. Analyst/Group Lead – Raw Materials will be expected to have subject matter oversight and expertise on raw material and incoming testing material processes, experience with international compendial test method performance.
Responsibilities (include but not limited to):
- Lead assigned staff by: driving organizational change; developing and empowering team; cultivating relationships; putting staff in a position to succeed, while also achieving organizational goals; building effective teams that apply diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
- Lead and maintain raw material program in compliance with regulatory requirements and commitments for clinical and commercial products.
- Manage qualified internal and contract laboratories for testing of GMP materials.
- Manage inspection process for incoming GMP material.
- Revise, review and approve raw material specifications in accordance with regulatory requirements and internal procedures.
- Manage and maintain the GMP material qualification process.
- Distribute the sampled materials to internal and external QC Labs
- Perform timely sampling and/or testing of raw materials, intermediates and final products by following analytical and microbiological Compendial methods (pH, Osmolality, Conductivity, Endotoxin, etc)
- Review final material packets and submit to QA for final disposition
- Maintain internal and external test results, and work with internal departments on timely raw material release.
- Report and manage internal or external out-of-specification results, investigations, CAPAs in timely manner to ensure appropriate immediate actions are taken
- Support internal and external audits, as necessary.
- Maintain, calibrate and operate equipment and instruments in the QC laboratory
- Monitor and trend data, complete routine record review of test data and related documents for raw materials.
- If necessary, ship the materials to outside testing labs
- Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.
- Supervise and guide raw material analyst/technicians.
- Interface with cross-functional groups such as product sciences, supply quality, quality assurance
- BS or advanced degree in Biochemistry, Chemistry or related Life Sciences
- 6+ years in a GMP environment (pharmaceutical or biotechnology industry) with at least 2 of those years in progressing roles supporting raw material programs
- At least 1 year of prior supervisory or lead experience preferred.
- Proven strong interpersonal, organization and problem-solving skills
- Solid knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to raw materials
- Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environment
- Knowledge of analytical, microbiology methods is strongly preferred.
- Experience managing suppliers and/or contract testing laboratories
- As a group lead, the ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
- Ability to manage timelines and coordinate work schedules of employees.
- Ability to travel up to 10% (role is primarily located in Tarzana, occasional travel to Thousand Oaks, as necessary).
- Ability to support occasional weekend work, as necessary.
- Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
- Experience with preparing regulatory documentation and inspection management
- Lead investigations in the case of non-conformances
- Auditing experience preferred.
- LIMS experience