Position Overview

We look for a highly energetic leader who has experience in cross functional project management and working knowledge of CMC operations. The candidate will be responsible for working directly with CMC leads to managing timelines, deliverables, and resources in CMC and Technical Operations. In addition to project management skills, the ideal candidate should also possess the ability to lead complex discussions, drive topics to closure, and engage and collaborate with internal and external partners in various functions. This position will play an important role in supporting across multiple programs in the cell and gene therapy space.

Primary Responsibilities:

• Good understanding of cGMP environment, and experience in managing complex projects / technical teams internally and/or externally.
• Ability to work with CMC Leads and stakeholders to manage workstreams independently
• Ability to effectively multitask and manage multiple complex program and above-program projects simultaneously
• Demonstrated history of aligning best practices across workstreams by developing standard reporting tools, metrics, agendas, minutes, and meeting structures.
• Maintain timelines, monitor program progress, and work with stakeholders to manage deliverables.
• Capability to rapidly assimilate, summarize and communicate complex topics to broader organization and leadership
• Identify and escalate risks or issues across programs and functions
• Ability to review, interpret and communicate data cross-functionally within CMC, project teams, and governance forums.
• Working knowledge of regulatory filings and workstreams desired

Qualifications:

• BS/MS in Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering or equivalent technical field. MBA / PMP a plus.
• Minimum 10 years of experience in a Pharmaceutical company or a CRO/CMO.
• Demonstrated experience leading complex projects in cross functional environments.
• Highly organized with an aptitude for technical project management
• External CDMO alliance management experience preferred
• Cell therapy experience preferred.
• Experience in supporting CMC Projects
• Experience managing internal and external stakeholder relationships
• Proficient in the use of project management tools such as smartsheets
• Independent thinker and team player.
• cGMP manufacturing knowledge.
• Good understanding of current regulatory landscape for cGMP manufacturing of nucleic acid molecules (DNA, mRNA, gRNA).
• Effective communicator.