Project Manager

Job Summary

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 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.
• Absorb and prepare for RFPs.

Job Requirements

• Requires a Master's degree in Regulatory Affairs, Quality Assurance Compliance, or related field and 3 years of related experience which must include some experience in each of the following skills:
• 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;
• Managing 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;
• Sets up and manages 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;
• Manages qualified external labs for product release and stability testing while ensuring timely material delivery and risk mitigation in sourcing plans.

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