Analyst, MS&T

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Manage Contract Manufacturing Organization (CMO) in the following areas: commercial product manufacturing (Drug Substance, Drug Product & Packaging) and testing laboratories (Quality Control for stability, In‑Process & Release testing). Primarily responsible for strategy establishment and implementation of new product launches, tech transfer, method/process/packaging validation, and CPM project financial tracking. Ensure an uninterrupted supply of commercial products to the marketplace.

• Manage and monitor production & testing activities in CMOs and handle associated issues.
• Perform technical review of CMOs’ protocols/reports, master/production batch records, testing methods, certificate of analysis, and change control.
• Provide technical insights and support during investigations of deviations as subject‑matter expert.
• Author/coordinate change controls and investigations accordingly.
• Author, review, monitor and maintain SOPs and guidelines.
• Manage archiving of GMP documents related to commercial manufacturing / packaging and testing.
• Lead process improvement initiatives at CMOs to improve quality and contribute to cost of goods reduction.
• Lead trending/monitoring programs at CMOs: continued process verification, annual product report, and stability trending.
• Lead commercial readiness activities: validation (analytical, process & packaging), risk assessment (critical process parameters), annual stability program template.
• Assist in writing and preparation of regulatory submission documents for drug product and drug substance sections in NDA, annual reports, and other regulatory dossiers.
• Assist in inspection or audit from Board of Health or SK LSI as subject‑matter expert.

• Prepare Request for Proposals (RFP) for CPM group projects.
• Review CMO project proposals.
• Prepare CMO vendor comparison and assist in selecting the appropriate CMO.
• Monitor operation team budget related to CMO.
• Prepare budget requests and amendments for new/ongoing projects.
• Maintain and monitor project budgets in SAP and Ariba systems.
• Process and pay CMO invoices via SAP/Ariba, preparing project‑specific budget summary tables to track spending.
• Review and forecast project budgeting.

• Serve as liaison between SK Biopharmaceuticals (SKBP) and CMOs to ensure forecasts are timely and accurate, preventing back‑orders.
• Work with CMOs to translate forecasts into a manufacturing schedule.

• Bachelor’s degree with 3‑4 years’ experience, or Master’s/Ph.D. with 1‑2 years of relevant experience.
• Minimum 3 years’ experience in the pharmaceutical/biotechnology industry.
• Ability to read, analyze, and interpret scientific and technical journals, financial reports.
• Expert technical skills, strong organization, mechanical aptitude a plus, good communication.
• Knowledge of protocols, SOP authoring, and technical manufacturing of drug substance, product & packaging.
• Working knowledge of cGMP requirements and applicable regulatory CMC documents.
• Ability to work successfully with multinational, interdisciplinary teams and influence collaborators.
• Knowledge of drug development processes and commercial manufacturing support.
• Familiarity with pharmaceutical package development and labeling (artwork) requirements.
• Ability to execute multiple projects under time & workload pressures.
• Excellent attention to detail while maintaining overall goal.
• Use communication skills to support project team within a matrix structure.

Seniority level:
Mid‑Senior level.

Employment type:

Full‑time.

Job function:
Business Development and Sales. Industry: Pharmaceutical Manufacturing.