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).
• Manage CPM project financial tracking.
• Ensure an uninterrupted supply of commercial product(s) to the marketplace.
Responsibilities
• Bachelor's degree or equivalent with 2-3 years' experience. Master's degree with 0 years of relevant experience.
• 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.
1.Technical Management
• Manage and monitor production & testing activities in CMOs and handle associated issues.
• Perform review of CMOs' Master/Production batch records, testing methods, certificate of analysis, change control, and protocols/reports.
• 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.
• Assist in trending/monitoring programs at CMOs: continued process verification, annual production report, water, and stability trending.
• 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 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.
2. Financial Management
• Prepare Request for Proposals (RFP) for the SCM 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.
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 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 2-3 years' experience. Master's degree with 0 years of relevant experience.
• Experience in pharmaceutical/biotechnology industry.
• Ability to multitask
• 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
• 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
Location: Paramus, NJ
Posted: Sept. 18, 2024, 9:41 a.m.
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