Workforce Genetics is recruiting for a Manager/Sr. Manager, CMC Project Management for a biotech company in Gaithersburg, MD.

About the company:

Our client is a privately held, clinical-stage, biotechnology company that has developed an investigational proprietary technology designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate a broad immune responses. The company is primarily focused on applying the platform in oncology where it could have broad applications. The company has built a strong pipeline of oncology programs, the lead of which is in a Phase 2 clinical study.

Overview of position:

As a result of the company's rapid growth, we are seeking a Manager/Sr. Manager, CMC Project Management who will work collaboratively with the Head of Operations/CMC team leaders, the CMC teams and the Product Development Teams (PDT) to ensure CMC project goals and milestones are achieved through effective management (organization, planning, execution and control) of all aspects of CMC projects. This is a newly formed position and is a key component of their expanding PMO.

Essential Functions

• Enable the seamless integration of CMC activities into the global product development strategy and plan.
• Translates the CMC project strategy into deliverables, activities, timelines and budget.
• Partners with the CMC team, and external vendors, to maintain the CMC project timelines and coordinate efficient execution.
• Ensures that all key stakeholders are knowledgeable of project milestones, plans, program status, and decisions through regular reporting and communication.
• Manages outside vendors and contractors as required.
• Leads risk identification, analysis and mitigation with the CMC team.
• Enables communications to align CMC project activities with PDT strategy, including planning of any necessary changes to the CMC deliverables, and aiding activities to secure PDT (Product Development Team) and Leadership support.
• Facilitates CMC Team meetings, is responsible for project logistics and will maintain easily accessible, easily understood project documents.
• Will forecast CMC project spend and oversee management of the budgeted project spend.
• Interfaces internally and externally as required to determine clinical and nonclinical material demand and will provide appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard.
• Communicates effectively with Operations, Process Development, GPM (Global Project Management), PDTs and with all interfacing functions and leadership as required.

Education and Experience

• Bachelor's, Master's, PhD or equivalent industry experience in a relevant technical discipline such as Biochemistry, Molecular Biology, Immunology or Chemical Engineering.
• Relevant training (PMP or equivalent) or experience in project management required.
• Senior Manager: 3 to 5 years of CMC Project Management experience is required.
• Manager: 1 to 2 years of CMC Project Management experience is required.
• Successful candidate must have experience in planning and managing the cross functional aspects of biopharmaceutical product development.
• The candidate will have demonstrated knowledge and application of Project Management tools, such as Risk Management.
• Effective working knowledge relevant to management of the technical disciplines of a CMC team is expected.
• Solid PowerPoint, MS Project, Excel and Word skills.
• Requires an ability to assess scientific data.
• Must be professional, dedicated, detail-orientated and comfortable with ambiguity.
• Excellent oral/written communication and interpersonal skills.
• Effective problem solving and analytical skills to tackle and solve a broad range of issues.
• Highly organized and able to work independently on multiple projects.
• PMP Certification preferred.
• Experience with Cellular and Gene Therapies (CGT) preferred.
• Lean Six Sigma certification (Green/Black Belt) preferred.