report to the Director, CMC Operations
support CMC leadership in the development and execution of operational plans
provide project management support to CMC team leads for key programs
facilitate development of and maintain adherence to project plans and timelines for key CMC activities
ensure alignment between CMC objectives and overall corporate strategy
liaise with project team members within CMC and across functions (including Quality and Regulatory) to drive successful completion of project deliverables
collaborate with Clinical Trials Supplies (CTS) to ensure production activities for Investigational Product (IP) meets clinical demand needs and associated timing
support in the preparation and review of regulatory filings, including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers
maintain executive project dashboards, working in close collaboration with other members of the CMC team responsible for API, DP, ARD/QC, and CTS
other duties as assigned.

Requirements

Bachelor’s degree in chemistry, chemical engineering, pharmaceuticals or biological sciences
minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry
minimum of 2 years’ experience with managing vendors/CDMOs/CROs
expertise in Microsoft Office, developing and maintaining detailed timelines (Gantt charts, Microsoft Project, etc.)
exceptional organizational skills and be detail oriented
excellent oral and written communication skills
Small molecule experience preferred
Project Management Professional (PMP) certification is a plus
expertise in Teams, SharePoint, Veeva, and SmartSheets is a plus

Benefits

health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
winter company shutdown
discretionary annual target bonus
stock options
401k match

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

project managementregulatory filingsGantt chartsMicrosoft Projecttimeline developmentsmall molecule experiencevendor managementCDMO managementCRO management

Soft Skills

organizational skillsdetail orientedoral communicationwritten communication

Certifications

Project Management Professional (PMP)