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 in the QC network. This will involve collaboration with key partner groups in our company to define solutions and implement them across the QC network.

In this role, the Data Steward will work with the Analytical Program Lead (APL) to ensure that digital solutions are available to support QC laboratories operating in a consistent manner using standard global analytical documentation. Data management and visualization will be supported to ensure data is available on demand for all necessary purposes across the network. This will include both assay monitoring and data trending (e.g. release data and proactive process analysis (PPA) data).

Furthermore, the Data Steward will organize external data oversight (from CMOs and CTLs) and will support the APL in the management of 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 in our company to QC laboratories. Collaborate with partners to support technology deployment and method implementation in a standard manner to all QC testing nodes.

• In collaboration with MS&T and QC partners, 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.

• MSc-level education or equivalent through experience

• At least 7 years’ experience in the pharmaceutical industry

• Basic understanding of the product development trajectory, regulatory filing requirements and existing regulatory GMP requirements (ICH, pharmacopeia)

• Affinity for digital solutions for assay monitoring and data trending

• Proven proactive, service-oriented and collaborative mindset

• High personal integrity, credibility and energy

• Excellent communication skills (verbal and written)

Adaptability, Analysis Method Development, Analysis 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

US and Puerto Rico Residents Only:
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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.

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