Associate, CMO Management

• Assist SKLSI CPM in the following areas: commercial product manufacturing (Drug Substance, Drug Product & Packaging), and testing laboratories (Quality Control for stability, In-Process & Release testing).

• Assist SKLSI CPM with project financial tracking.
• Assist SKLSI CPM to ensure an uninterrupted supply of commercial product(s) to the marketplace.

• Associate’s degree or equivalent.
• 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.
• Good to excellent working knowledge of Word, Excel, and PowerPoint.
• Ability to execute activities simultaneously on multiple projects under pressures of time and workload.
• Attention to detail without losing sight of the overall goal.

1. Technical Management.  Assist with

• Monitoring production & testing activities at CMOs and handle associated issues.
• Reviewing batch records, testing methods, certificates of analysis, and protocols/reports.
• Reviewing and authoring change controls and investigations.
• Reviewing, authoring and maintaining SOPs and Guidelines.
• Management and archiving of GMP documents related to commercial manufacturing / packaging.
• Trending/monitoring programs at CMOs: continued process verification, annual production report, stability analysis.
• Commercial readiness activities: validation (Analytical, Process & Packaging), risk assessment (critical process parameter), annual stability program template.
• Preparation of regulatory submission documents: drug product and drug substance sections in NDA, Annual reports, and other regulatory dossiers.
• periodic inspection/audit from Board of Health or SKLSI QA.

2.Financial Management.  Assist with:

• Preparing Request for Proposals (RFP) for CPM group projects
• Reviewing project proposals
• Preparing CMO RFP comparison and assist with selecting the appropriate CMO
• Monitoring operation team budget related to CMO.
• Preparing budget requests and amendments of new/ongoing projects.
• Managing project budgets in SAP and Ariba systems.

3. 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 the product is delivered on time and back orders are avoided.
• Working with CMOs to ensure that forecast is translated into a manufacturing schedule.

• Associate’s degree or equivalent with 2-3 years’ experience.
• Experience in pharmaceutical/biotechnology industry a plus.
• Ability to multitask
• Maintain composure under pressure
• Ability to follow verbal or written instructions and use effective verbal communications
• Adapts change, adjust change and grasps information quickly
• Examine and observe details
• Good organization skills, ability to follow direction, mechanical aptitude a plus, good communication skills.
• Ability to work successfully within a multinational environment.
• Ability to execute activities simultaneously on multiple projects under pressures of time and workload.
• Excellent attention to detail without losing sight of overall goal