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.

Key activities and responsibilities

• 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.

Qualifications & Experience

• 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)

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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