Manager, CMO (Contract Manufacturing Organization) Management

Company Details

SK Life Science, Inc.

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).
  • Perform technical review and approval on documents from CMOs.
  • Plan and execute in support of commercial readiness activities.
  • Manage SCM project financial tracking and forecasting commercial supply requirements.
  • Ensure an uninterrupted supply of commercial product(s) to the marketplace.

Responsibilities:

1. Technical Management
  • Manage and monitor production & testing activities in CMOs and handle associated issues.
  • Perform technical review of CMOs’ Master/Production batch records, testing methods, certificate of analysis, change control, and protocols/reports.
  • Provide technical insights and support during investigations of deviations as Subject Matter Expert (SME).
  • Author/coordinate change controls and investigations accordingly at SK life science, Inc. (SK LSI).
  • Review, monitor and maintain SCM SOPs/Guidelines at SK LSI and CMOs.
  • Manage archiving of SCM 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 production report, water, and stability trending.
  • Work with CMO package engineers to implement serialization of all product packages.
  • Work with CMO package engineers when developing/improving package designs.
  • Assist in 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 IND, NDA, Annual reports, and Information amendments.
  • Assist in inspection or audit from Board of Health or SK LSI (review of CMC documents, etc.), as subject matter expert.

2. Financial Management
  • Prepare request for proposals (RFP) for the SCM group projects
  • Review CMO project proposal prior to selecting the vendor
  • Prepare CMO vendor comparison and assist to select the appropriate CMO
  • Monitor SCM operation team budget related to CMO.
  • Prepare budget requests and amendments of new/ongoing SCM projects and supply for the SCM Group.
  • Prepare, maintain, and monitor SCM 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.
  • Assist in the budgeting process.
  • Review and forecast project budgeting.

3. Communications Management
  • Serve as a line of communication between SK biopharmaceuticals (SKBP) SCM 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:

Education Preferred:
  • Bachelor’s degree or equivalent with 7-10 years’ experience. Pharm.D., Master’s degree or Ph.D. with 3-5 years of relevant experience.

Work Experience:
  • At least 5 years’ experience in a Supply Chain role.

Physical and Mental Requirements:
  • Ability to multitask
  • Adapts to change
  • Maintain composure under pressure
  • Ability to follow verbal or written instructions and use of effective verbal communications
  • Adapts change, adjust change and grasps information quickly
  • Examine and observe details

Other:
  • 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.

To apply for this job please visit www.indeed.com.

AllEscort