Associate Director / Director CMC Project Management Details

Associate Director / Director CMC Project Management

SwanBio Therapeutics - Philadelphia, PA

Employment Type : Full-Time

About SwanBio Therapeutics

SwanBio is a privately held, newly established biotechnology company focused on the discovery and development of innovative gene therapy products for the treatment of central nervous system (CNS) disorders and diseases. SwanBio has a deeply experienced leadership team and is building an open, innovative culture that trusts its people, processes and science to deliver scientific, clinical and business success.SwanBio's lead investor is Syncona, a premiere investment partner focused on building companies delivering transformational healthcare treatments. Syncona has a deep pool of capital and they are established leaders in the development of genetic medicine. In particular, they present a legacy of success in long term investment strategies for companies in the Gene and Cell Therapy space. Our goal is to become a world-leader in treating neurodegenerative diseases. With locations in Philadelphia and Boston, the SwanBio Team is building a strong pipeline of gene therapy development programs with a directed focus on critical unmet medical needs for CNS diseases. SwanBio offers all team members both competitive compensation and benefits.

The Opportunity

SwanBio Therapeutics seeks an experienced and highly skilled project manager to build out the company's integrated operational plans for CMC activities as well as own and manage the execution of these program plans, timelines, risks/mitigations and budget. They will support the Quality, and Technical Operations Functions to deliver CMC activities for both pre-clinical and clinical programs. This is a critical role within the company with responsibility to track key development milestones and dependencies and will be at the center of a cross-functional organization. They will be an integral supporting member of the Program Team and responsible for helping to build CMC capabilities and achieve key CMC milestones. It is essential that the incumbent is a strong and collaborative team member, capable of working across functions in drug development, with the ability to create platforms which capture strategy and operational dependencies

Key Responsibilities

In this role you will:

• Manage operational and execution aspects of programs of varying complexity, independently, within the CMC team, within program team(s) and across R&D departments (Research, Clinical, Regulatory and Manufacturing).
• Develop, maintain and track high-level and detailed program development integrated timelines, ensuring consistency with input from functional team representatives and overall program leadership.
• Work closely with functional representatives to ensure that mid-term and longer-term timelines remain aligned with the integrated program timelines and overall program plans.
• Raise potential problems / conflicts / issues with program timelines, risks, or budget to CMC and program leadership and participate in the problem-solving and resolution of potential on-going program operational challenges.
• Anticipate CMC drug development needs proactively and raise cross functional topics/issues for the team to consider that are 12-24 months ahead.
• Identify, communicate and continually manage program action items and risks registers in relation to program activities.
• Prepare and maintain project update/progress reports and timeline revisions, as required.
• Provide oversight to ensure that decisions made at the program level are assessed regarding their impact on CMC plans, budget and resource availability.
• Support financial oversight of ongoing programs, including working closely with Finance in budget creation, reviews, accruals and forecasts.
• As part of Program Management, recommend and implement best practices (e.g., monthly dashboards for portfolio review, risk management logs, action item logs, resource planning).
• Present program operational updates to senior leadership and colleagues, where relevant, on a regular basis within routine company meetings
• Assist in developing and managing communications (regular reporting of project timeline and spend vs. budget) to team leader, project team members and/or program management/senior management
• Assist in the preparation of purchase order requisitions and working with the CMC team interact with external (vendor) project managers to ensure accurate reporting of progress

Basic Requirements:

• BS / MS Degree in Business, Life Science, engineering or related field
• 5-8 years of Life Science Project Management
• CMC experience preferably in early stage clinical trials
• Gene and/or Cell Therapy experience highly preferred
• Experience in small molecules, biologics, and/or vaccines required
• Broad knowledge of project management best practices and proficiency with project management tools
• PMP certification is a plus

Skills

• Exceptional Analytical and Problem Solving Skills
• Ability to operate in a fast paced, deadline sensitive environment
• Ability to work comfortably under pressure and adapt to changing priorities and deadlines
• Ability to think strategically with strong business judgment
• Willingness to take on multiple responsibilities at once
• Resourceful and a self-starter
• Able to operate independently
• Excellent verbal and written communication skills
• Possess a startup mindset of no job too big or to small

About the Benefits:
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs including bonus and stock option plans. Additionally, SwanBio Therapeutics offers all team members a comprehensive benefits program including medical, dental, vision care, 401(k), paid vacation and holiday time.

SwanBio Therapeutics is an equal opportunity employer