Senior Manager, CMC Project Management

4DMT is seeking a Sr. Manager, CMC Project Management, to join its Project Management team and ensure the progress and success of the clinical stage assets at 4DMT.

The ideal candidate will successfully leverage their prior CMC technical and drug development experience in complex biologics to partner with the chemistry manufacturing and controls/technical operations and the cross-functional teams to effectively drive the clinical development of 4DMT’s therapeutic assets in clinical development.

Experience and a deep understanding of the CMC development and GMP manufacturing requirements in all stages of drug development, from discovery to late-stage clinical development, is critical to the success of this role.

• Manage internal CMC project's scope, timelines, budget, risks, and documentation of meetings
• CDMO project management includes processing various legal documents and contracts needed to work with CDMOs.
• Identify project risks and proactively facilitate mitigation strategies and resolution.
• Ensure relevant communication and alignment across CMC departments as appropriate.
• In collaboration with Tech Ops leadership, create mid- and long-term project strategies and help determine the CMC needs of programs alongside CMC and similar colleagues.
• Responsible for ensuring flawless and smooth execution of CMC deliverables according to defined timelines and cost via leading multidisciplinary CMC teams as well as preparing accurate CMC updates for key stakeholders, including the Executive Team.
• Effectively present information, respond to questions and facilitate communications regarding CMC updates, program risks, and business impacts across the organization when required.
• Support development, implementation, and adherence to operational procedures throughout the organization.
• Other duties as assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Education: 

• Bachelor’s degree in life sciences or a relevant field. Advanced degree in life sciences preferred.

Experience: 

• 8+ years of hands-on technical experience in biologics manufacturing or development (e.g., process development, cGMP manufacturing, process registration, analytical science), preferably in viral vector production, preferred
• 5 + years of experience in CMC project management
• Record of accomplishment of successfully managed CMC projects and personnel
• Leadership and motivational soft skills to maintain naturally high morale within the CMC team
• Ability to communicate effectively at all levels across the organization. Has strength of character to have difficult conversations with senior stakeholders, including customers, internal team members, and senior management; excellent written, verbal, and presentation skills
• Ability to function independently in a fast-paced environment.
• Pragmatic, organized, and results-oriented and with the ability to manage multiple priorities
• Excellent planning, organizational, and controlling skills
• Problem-solving skills - ability to analyze using critical thinking and solve complex issues that do not have routine solutions and propose solutions
• Skilled with Microsoft Project, Teams, and other automated presentations
• Must have sound knowledge of integrated drug development processes in a biopharmaceutical company. Experience with gene or cell therapy programs preferred.
• Ability to manage multiple work streams and projects concurrently.
• Excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly.

Skills: 

• Proficient in the Microsoft Suite of programs
• MS Project
• OnePage

Base salary compensation range: $153,000 - $198,000

Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience