Data Steward - Associate Principal Scientist, Analytical R&D

Job Description

The GQLMAS Data Steward will support implementation of standard digital solutions for analytical method transfer, analytical method execution and assay monitoring within the QC network. This involves collaboration with key partner groups to define solutions and implement them across QC laboratories. The Data Steward works with the Analytical Program Lead (APL) to ensure digital solutions are available to support QC laboratories operating consistently with standard global analytical documentation.

Data management and visualization are supported to ensure data is available on demand for all necessary purposes across the network, including assay monitoring and data trending.

The role also includes organizing external data oversight from CMOs and CTLs and supporting the APL in managing stability data for filing and response‑to‑question (RtQ) purposes.

• Support the creation of digital method and assay monitoring solutions across the end‑to‑end analytical lifecycle for QC laboratories.
• Collaborate with partners to support technology deployment and method implementation in a consistent standard manner across all QC testing nodes.
• Develop standard processes to collect, organize, analyze and interpret analytical release, stability and in‑process data across internal and external testing nodes.
• Support maintenance of standard execution approaches across testing nodes via digital solutions.
• Support change control for digital methods to ensure changes are rigorously reviewed and implemented in a standard manner across QC testing nodes.
• Support creation of data reporting tools to facilitate regulatory filings, RtQ, stability period assignment, investigations and analytical method performance verification.

• San Francisco Residents Only
• Los Angeles Residents Only (in accordance with local laws)

• MSc‑level education or equivalent through experience.
• At least 7 years of experience in the pharmaceutical industry.
• Basic understanding of the product development trajectory, regulatory filing requirements and existing GMP requirements (ICH, pharmacopeia).
• Affinity for digital solutions for assay monitoring and data trending.
• Proactive, service‑oriented and collaborative mindset.
• High personal integrity, credibility and energy.
• Excellent communication skills (verbal and written).

• Adaptability
• Analytical Method Development
• Analytical Method Transfer
• Assay & Assay Development
• Biochemical Assays
• Biological Assay Development
• Cell‑Based Assays
• Chromatographic Techniques
• Collaborative Development
• Cross‑Functional Teamwork
• Data Monitoring
• Data Stewardship
• External Collaboration
• GMP Compliance
• High‑Performance Liquid Chromatography (HPLC)
• Optimism
• Pharmaceutical Management
• Process Analytical Technology (PAT)
• Product Development
• Protein Analysis
• Quantitative Assay
• Strategic Collaborations
• Teamwork

• None specified.

Salary range: $ – $ (based on several factors including education, experience, location).

Benefits include:

• Medical, dental, vision and other insurance (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, compassionate and sick days

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement.