Analyst, MS&T

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.

Technical Management

Manage and monitor production & testing activities in CMOs and handle associated issues.
1. Perform technical review of CMOs' protocols/reports, Master/Production batch records, testing methods, certificate of analysis, and change control.
2. Provide technical insights and support during investigations of deviations as Subject Matter Expert (SME).
3. Author/coordinate change controls and investigations accordingly.
4. Author, review, monitor and maintain SOPs/Guidelines.
5. Manage archiving of GMP documents related to commercial manufacturing / packaging and testing.
6. Lead process improvement initiatives at CMOs to improve quality and contribute to Cost of Goods reduction.
7. Lead trending/monitoring programs at CMOs: continued process verification, annual product report, and stability trending.
8. Lead commercial readiness activities: validation (Analytical, Process & Packaging), risk assessment (critical process parameter), annual stability program template.
9. Assist in writing and preparation of regulatory submission documents: drug product and drug substance sections in NDA, Annual reports, and other regulatory dossiers.
10. Assist in inspection or audit from Board of Health or SK LSI (review of CMC documents, etc.), as subject matter expert.

Financial Management

1. Prepare Request for Proposals (RFP) for the CPM group projects
2. Review CMO project proposal
3. Prepare CMO vendor comparison and assist to select the appropriate CMO
4. Monitor operation team budget related to CMO.
5. Prepare budget requests and amendments of new/ongoing projects.
6. Prepare, maintain, and monitor Project budgets in SAP and Ariba systems.
7. 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.
8. Review and forecast project budgeting.

Communications Management

1. 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.
2. Working with CMOs to ensure that forecast is translated into a manufacturing schedule.

• 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.