Project ManagerRegular Full-Time
Boulder, CO, US
Salary Range: $157,227.00 - $178,972.00 /year
JOB SUMMARY:Corden Pharma Colorado, Inc. seeks 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.
- Assist with the preparation of RFPs.
JOB REQUIREMENTS: Requires a Master's degree in Regulatory Affairs, Quality Assurance Compliance, or related 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;
- 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; and
- Managing qualified external labs for product release and stability testing while ensuring timely material delivery and risk mitigation in sourcing plans.
This posting will expire on July 22, 2026.
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
