ZS · 2 months ago
Business Technology Solutions Consultant - CMC
Multiple
Full-time
Onsite
Senior Level
6+ years expZS is a management consulting and technology firm focused on improving life through data, science, and technology. They are seeking a Business Technology Solutions Consultant to deliver projects in the pharmaceutical CMC development area, leveraging expertise in digital laboratory systems and regulatory compliance to support clients' workflows.
ConsultingManagement ConsultingMarketing
Responsibilities
Support clients in implementing and optimizing digital laboratory systems (e.g., LIMS, ELN) and ensuring GLP-aligned data management practices within CMC development workflows
Configuring and deploying LIMS for sample management, workflow automation, and regulatory reporting
Implementing and integrating ELN for standardized documentation and cross-team collaboration
Ensure GLP compliance by maintaining audit readiness, data integrity, and regulatory alignment
Partner with scientists, quality, and IT teams to digitize and scale laboratory workflows
Validate and ensure compliance of laboratory informatics and data management solutions with industry standards and regulatory expectations
Undertake and oversee complete ownership in accomplishing activities and assigned responsibilities across all phases of project lifecycle to solve business problems across multiple client engagements and programs
Apply appropriate development methodologies (e.g.: agile, waterfall) and best practices (e.g.: mid-development client reviews, embedded QA procedures, unit testing) to ensure successful and timely delivery of projects and programs
Collaborate with other team members across functions to leverage expertise and ensure seamless transitions; Exhibit flexibility in undertaking new and challenging problems and demonstrate excellent task management
Create project outputs such as business case development, solution vision and design, user requirements, prototypes, and technical architecture (if needed), test cases, and operations management
Assign tasks across teams and assess timely status for project progress
Bring Consulting mindset in problem solving, innovation by leveraging technical and business knowledge/ expertise and collaborate across other teams
Guide teams to build complex solutions using Programing languages, ETL service platform, etc
Upskill on technologies and concepts relevant to solve client problems across modalities
Discuss and determine with clients which specific data may be best utilized in order to perform the necessary analysis
Evaluate, assess and analyze the data necessary to provide solutions to the clients' particular business information needs
Be available for clients during regular working hours
Qualification
Required
Bachelor's (and often graduate) degree in Chemical Engineering, Mechanical Engineering, Chemistry, Computer Science, Biotechnology or similar degree
6-8 years of experience working in a pharmaceutical CMC organization
Hands-on experience with at least one of the functions in CMC development such as Process Chemistry, Process Engineering, Formulation, and Analytical Chemistry
Knowledge of key concepts including unit operations, processes, quality by design (QbD), tech transfer, process validation, quality attributes, and regulatory milestones across pharma development
Understanding of the different data and information systems such as ELN, LIMS, ERP systems, and LCM or PLM systems, and experience in implementing and optimizing these systems
Proven experience in embedding GLP-compliant practices in these systems to ensure data integrity, regulatory readiness, and efficiency in CMC workflows by maintaining audit readiness, data integrity, and regulatory alignment
Experience partnering with scientists, quality, and IT teams to digitize and scale laboratory workflows
Understanding of the CMC related regulatory submission requirements
Solid understanding of drug manufacturing validation principles and compliance requirements
Solid experience in system validation and qualification protocols in GxP environments, ensuring compliance with industry standards and regulatory requirements
Experience presenting to senior leaders, executives, and audiences with CMC backgrounds
Ability to lead multiple workstreams and demonstrate effective time and project management skills
Strong ability to identify data anomalies, design data validation rules, and perform data cleanup to ensure high-quality data
Project management and task planning experience, ensuring smooth execution of deliverables and timelines
Strong communication and interpersonal skills to collaborate with both technical and non-technical teams
Experience with automation testing
High motivation, good work ethic, maturity and personal initiative
Self-discipline for planning and organizing tasks
Capable of managing a virtual global team for the timely delivery of multiple projects
Experienced in analyzing and troubleshooting interactions between databases, operating systems, and applications
Travel to global offices as required to collaborate with clients and internal project teams
Preferred
Experience with at least one tech transfer, exposure to analytics, AI and/or technology implementation in CMC
Benefits
Health and well-being
Financial planning
Annual leave
Personal growth and professional development
Robust skills development programs
Multiple career progression options
Internal mobility paths
Collaborative culture
Company
ZS is a management consulting and technology firm that partners with companies to improve life and how we live it.
10001+ employees
H1B Sponsorship
ZS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (351)
2024 (297)
2023 (251)
2022 (440)
2021 (292)
2020 (164)
Funding
Current Stage
Late StageLeadership Team
Arun Shastri
Principal
Victoria L Summers
Principal
Recent News
2025-12-30
2025-12-11
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