Denver, CO 80301
Manage resources and cross-functional efforts to successfully achieve customer deliverables and project objectives for contracted development and technical transfer of active pharmaceutical ingredients and intermediates.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Drive adherence to the company’s contractual commitments: develop project plan including resources, timing, milestones, and deliverables. Track, monitor, and report key performance metrics including expenditures v. 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.
- Monitor trends and drive continuous improvement of the project management process
- 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 to quality product requirements.
- Assist with the preparation of RFP's
EDUCATION AND EXPERIENCE
Minimum BS in Chemistry or Chemical Engineering. Ten years’ experience in Pharma industry, with at least 5 years in Project Management or equivalent combination of education and experience and experience in API process development and external customer communications.
- Working knowledge of biotech/pharma manufacturing operations, product and process development, and supply chain operations in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, practices, and statues.
- Demonstrated outstanding customer service skills.
- Effective verbal, written, and interpersonal communication skills.
- Good business negotiation skills
- Excellent leadership and influencing skills in a diverse team environment
- Excellent organizational and time management skills. Capable of handling multiple tasks/projects.
- Effective leadership and influencing skills.
- PC skills to include MS Word, Xcel, and Project.
- Adaptable to managing change.
- Recognize opportunities and/or issues and applies analytical and creative thinking to maximize performance.
- Broad, demonstrated expertise in synthetic API process development, improvement, and technical transfer is a plus