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USA - Delaware - Wilmington (Biotech), United States of America
Hybrid
Not Available
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:
Adaptability, 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 {+ 1 more}Preferred Skills:
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The salary range for this role is
$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (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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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
07/22/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.