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Quality Engineering

Analyst, MS&T

Job in Paramus, Bergen County, New Jersey, 07653, USA
Listing for: SK Life Science
Full Time position
Listed on 2025-11-20
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 100000 - 125000 USD Yearly USD 100000.00 125000.00 YEAR
Job Description & How to Apply Below

Job Title: Analyst, MS&T

Job Location s: US-NJ-Paramus

Job :

Overview

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 the following, but not limited to; strategy establishment and implementation of New product(s) launch, tech transfer, method/process/packaging validation, etc.

Manage CPM project financial tracking.

Ensure an uninterrupted supply of commercial product(s) to the marketplace.

Responsibilities Technical Management
  • 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 (SME).
  • Author/coordinate change controls and investigations accordingly.
  • Author, review, monitor and maintain SOPs/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 parameter), annual stability program template.
  • Assist in writing and preparation of regulatory submission documents: 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 (review of CMC documents, etc.), as subject matter expert.
    • Financial Management
  • Prepare Request for Proposals (RFP) for the CPM group projects
  • Review CMO project proposal
  • Prepare CMO vendor comparison and assist to select the appropriate CMO
  • Monitor operation team budget related to CMO.
  • Prepare budget requests and amendments of new/ongoing projects.
  • Prepare, maintain, and monitor Project budgets in SAP and Ariba systems.
  • Review, process and pay CMO invoices via SAP / Ariba systems in support of projects and prepare project specific budget summary table to track and trend of project spending.
  • Review and forecast project budgeting.
    • Communications Management
  • Serve as a line of communication between SK biopharmaceuticals (SKBP) and the CMOs to ensure that forecasts are timely and accurate. Ensure that product is delivered on time and back orders are avoided.
  • Working with CMOs to ensure that forecast is translated into a manufacturing schedule.
    • Qualifications
    • Bachelor's degree or equivalent with 3-4 years' experience. Master's degree or Ph.D. with 1-2 years of relevant experience.
    • At least 3 years' experience in pharmaceutical/biotechnology industry
    • Ability to read, analyze, and interpret common scientific and technical journals, financial reports.
    • Expert technical skills, good organization skills, ability to follow direction, mechanical aptitude a plus, good communication skills.
    • Understand protocols, authoring SOPs, and technical knowledge of the manufacturing and testing drug substance, drug product & packaging.
    • Working knowledge of and experience with cGMP requirements, and applicable regulatory CMC documents.
    • Ability to work successfully with multinational, interdisciplinary project teams and proven ability to influence and collaborate effectively.
    • Working knowledge of drug development processes and technical support of commercial manufacturing.
    • Familiarity with pharmaceutical package development and labeling (artwork) requirements.
    • Ability to execute activities simultaneously on multiple projects under pressures of time and workload.
    • Excellent attention to detail without losing sight of overall goal.
    • Use communication skills to support project team as part of a matrix organizational structure.
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