Job Information
SK Life Science, Inc Analyst, CMO Management in Paramus, New Jersey
Analyst, CMO Management
Job LocationsUS-NJ-Paramus
ID | 2024-1856 | Category | Other | Type | Regular Full-Time |
- Manage CPM project financial tracking.
- Ensure an uninterrupted supply of commercial product(s) to the marketplace.
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).
- 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.
- 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 overall goal.
- Use communication skills to support project team as part of a matrix organizational structure.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.