Project Mgr.
About The Position
Corden Pharma Colorado, Inc. seeks a Project Manager in Boulder, CO to review and update standard operating and quality assurance procedures, monitor performance of quality control systems, and analyze quality control test results. The role involves developing project plans, tracking key performance metrics, managing multiple projects, and acting as a liaison between the company and customer project managers. The Project Manager will also develop periodic reports on project performance, identify and resolve issues affecting project goals, ensure risk assessments and mitigation plans are in place, collaborate with R&D, Quality, and Operations, and assist with RFP preparation.
Requirements
- Designing and executing synthetic routes for small molecule APIs, including flow chemistry and batch chemistry, with a focus on scale-up from lab to GMP manufacturing
- Manage end-to-end tech transfers of drug substance and drug product manufacturing processes, including documentation package preparation, process fit assessments, and site-to-site alignment
- Overseeing manufacturing campaigns within GMP environments, including deviation tracking, batch record reconciliation, and ensuring adherence to regulatory and internal quality systems
- Setting up and managing stability studies for drug substances/products in accordance with ICH Q1A(R2) including sample pull schedules, data trending, and report generation
- Coordinating with analytical teams to ensure analytical methods are fit-for-purpose, validated per ICH Q2(R1) standards, and successfully transferred to internal or external QC labs
- Managing qualified external labs for product release and stability testing while ensuring timely material delivery and risk mitigation in sourcing plans
Responsibilities
- Review and update standard operating and quality assurance procedures.
- Monitor performance of quality control systems to ensure effectiveness and efficiency.
- Analyze quality control test results and provide feedback and interpretation to production management or staff.
- Develop project plan including resources, timing, milestones, and deliverables for company’s contractual commitments.
- Track, monitor, and report key performance metrics including expenditures vs. budget.
- Manage and control multiple projects to meet objectives.
- Act as a liaison between the company and customer project manager to ensure mutual agreement of contract scope and schedule.
- Develop and distribute periodic reports on project performance, issues, risks, and schedules of key activities, events, or milestones.
- Identify, escalate, and facilitate resolution of manufacturing, supply chain, or quality issues that may adversely affect project performance goals.
- Ensure risk assessments and appropriate risk mitigation plans are established for projects at every phase of the contract.
- Collaborate with R&D, Quality, and Operations to understand critical quality product requirements.
- Assist with the preparation of RFPs.
Benefits
- 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
- Accident Plan
- Critical Illness Insurance
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft Protection
- Life Insurance
- Paid Maternity/Paternity Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
