Associate Director, CMC Project Management

Job Title: Associate Director, CMC Project Management

Job Number: 35368

Location: , 

Job Description

We are seeking an Associate Director, CMC Project Management to join the Technical Operations team at Apogee. This role will be responsible for handling all aspects of the external CDMO relationship for one of our CMC Programs including, but not limited to: meetings, timelines, tech transfer, DS/DP manufacturing, all related documentation via managing the exchange of information via internal and external SharePoint sites, as well as provide Project Management support for our other CMC Programs. The individual hired will also focus on operational excellence creating efficiencies and standardizations to ensure streamlined processes.  This position requires a self-starter, who can organize projects effectively in a fast-paced setting. If you are interested in utilizing your CMC Project Management expertise to deliver innovative medicine to the patients, enjoy the fast-paced environment and thrive in a culture of growth and camaraderie, this role is for you.  

Responsibilities

• Manage all operational and project management aspects of the external CDMO relationship
• Work with Tech Ops team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth
• Provide Project Management support for one of our CMC programs, including building and maintaining the CMC timelines by interfacing with our external partners and facilitating cross-functional collaboration with the Tech Ops
• Collaborate closely with the cross-functional Program Management team to ensure integration of Tech Ops activities into overall program plans, monitor project deliverables and ensure tasks are on track
• Create efficiencies for processes and streamline operational activities
• Review and approve vendor accruals and invoices
• Assist with tracking outsourced activities as needed

Required Skills

• Bachelor’s degree in science
• 10+ years of experience in biotech or pharmaceutical industry with 5-8 years of Biologics development and manufacturing experience
• 5+ years of Technical Operations/CMC Project Management experience
• Experience working with clinical stage candidates across all phases of Clinical Development (e.g., PhI to PhIII). Experience with Late Stage (Process Characterization and PPQ) is a plus
• Good technical knowledge of CMC development, CMC Regulatory Affairs, Quality, GMP requirements and device
• High level of expertise of Smartsheet, Microsoft Project, OnePager, and Office Timeline
• Assertive and proactive
• Highly organized with meticulous attention to detail
• Ability to multi-task and keep pace with a fast-moving organization
• Ability to participate in calls across multiple international time zones
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 15% to company All Hands Meetings, and the Apogee lab in Boston

The anticipated salary range for candidates for this role will be $175,000 – $190,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.