Senior Scientist, Process Impurities Development; Analytical Development, Process Impurities, Method Development Reports to: Associate Director, Analytical Ops
Job Overview:We are seeking a highly motivated Research Scientist to join our Process Impurities Development team within the Method Development and Automation function. This role primarily focuses on the development, optimization, and deployment of analytical methods supporting impurity, compendial, and safety testing and raw material characterization to support gene and cell therapy development and commercialization.
The successful candidate will bring strong experience in this area, along with a working knowledge of ICH, USP, and EU regulatory guidelines. You will play a critical role in ensuring product safety and consistency by supporting process development and tech transfer activities across the organization.
Key Responsibilities:- Serve as SME for compendial methods (USP, Ph. Eur.), including appearance, pH, osmolality, particulates, and safety-related assays (e.g., sterility/CCIT, mycoplasma, endotoxin) and process impurity immunoassays (e.g., ELISA, Ella, Luminex).
- Own method development, optimization, robustness, and troubleshooting, as well as gap assessments, and equivalency justifications.
- Provide technical input to QC readiness, method deployments, and external partner strategy.
- Author, revise, and approve compendial methods, protocols, and verification/compliance summary reports in alignment with internal standards and pharmacopeial expectations.
- Support method verification, validation, and lifecycle maintenance activities in accordance with ICH Q2 and compendial requirements.
- Support deviations, investigations, and CAPAs related to compendial and safety assays as a technical SME.
- Act as a technical liaison between Analytical Ops, Quality, Manufacturing, Regulatory, and external partners.
- Ensure patient and product safety through rigorous execution and oversight of safety analytical testing.
- Identify, assess, and mitigate analytical risks related to compendial methods, raw materials, and in-process controls.
- Communicate risks, timelines, and compliance considerations clearly to stakeholders and leadership.
- Contribute to standardization and continuous improvement of compendial practices across programs.
- Document experimental protocols, reports, and supporting SOPs in accordance with GDP and regulatory standards.
- Maintain compliance with GMP and internal quality systems.
Basic Qualifications:- PhD (0+ years) in Biochemistry, Molecular Biology, Analytical Chemistry, or other related discipline OR
- MS with 6+ years of relevant industry experience in analytical development, QC, or regulated testing environments OR
- BS with 8+ years of relevant industry experience in analytical development, QC, or regulated testing environments.
Preferred Qualifications:- 4+ Years with PhD in Biochemistry, Molecular Biology, Analytical Chemistry, or other related discipline
- Operates independently with limited oversight and exercises sound scientific judgment.
- Recognized within the group as a go-to resource for compendial and safety testing, with the ability to independently represent analytical risk, compliance impact, and recommended path forward.
- Proactively identifies gaps and risks, supports equivalency assessments and compliance justifications, and translates ambiguity into clear study plans, decisions, and stakeholder updates.
- Mentors junior staff, provides technical guidance to peers, and supports cross-training and knowledge transfer within Analytical Ops and QC-facing activities.
- Proven experience with impurity immunoassays and/or compendial and safety methods including development/optimization, troubleshooting, and readiness for QC or transfer into routine testing in alignment with ICH Q2(R2), USP, and Ph. Eur. guidelines.
- Critical reagent strategy experience, including qualification, lot-to-lot bridging, and supply continuity risk mitigation.
- Experience supporting GMP/QMS investigations and driving scientifically justified CAPAs related to compendial, safety, and impurity assays.
- Proficiency in data analysis using software such as JMP.
- Excellent technical writing skills for protocols, reports, and submissions.
- Strong collaborative mindset and communication skills.
- Comfortable working in a dynamic biotech environment with evolving priorities and timelines.
Why Join Us? Join a forward-thinking team focused on enabling the development of next-generation CAR T and gene therapies. In this role, you will have a direct impact on ensuring the safety and quality of our cutting-edge therapies by shaping and executing analytical strategies for process impurities. We offer a collaborative and fast-paced environment where you can grow technically and professionally while helping advance transformative treatments for patients in need.
The salary range for this position is: $153,935.00 - $199,210.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
