Director, CMC Management at Dyno Therapeutics

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor's Degree in Science or related field, or equivalent with 8-10 years of related work experience, or advanced degree and a minimum of 6 years of work experience
Project and portfolio management certificate or expertise; deep knowledge of project management tools e.g. Smartsheet, MS Project, dashboards
Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments
Ability to work, influence, and gain consensus across multiple functions (CMC, Quality and Regulatory Affairs)
Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, including IND, BLA, and post-approval changes
Strong analytical, problem solving and critical thinking skills; highly organized
Collaborative work style to be part of a team to identify process gaps and develop solutions
Excellent interpersonal, verbal, and written communication skills with the ability to work in strong cross-functional relationships and communicate complex issues enterprise-wide, from the executive team to the manufacturing floor
Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors

Responsibilities

Lead project and portfolio management function to develop CMC timelines, risk register, budgets working with CMC teams (collaborate with CMC, Supply, Quality Control, Quality Assurance, and Clinical Operations)
Act as main point of contact for CMC team leaders including working subteams and strategic business teams
Responsible for supporting CMC teams with long term strategic plans including LRP, budget planning and timelines across the portfolio
Prepare management review presentations with expertise in Smartsheets or MS Project
Develop and maintain dashboards, Sharepoint folders and repository for CMC plans for each program
Support CTO with LRP, timelines and budget planning across Tech Ops/CMC
Act as collaboration point of contact with Dyne PMO and program managers
Organize and maintain documentation related to project plans
Support Reg CMC with submission timelines e.g. reviews, approvals internally within CMC
Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration

Skills

Key technologies and capabilities for this role

SmartsheetMS ProjectSharePointProject ManagementPortfolio ManagementRisk RegisterBudget PlanningTimeline ManagementCMC ManagementLong Range PlanningDashboardsRegulatory CMC

Questions & Answers

Common questions about this position

What is the location for this role?

This role is based in Waltham, MA.

What education and experience are required?

A Bachelor's Degree in Science or related field with 8-10 years of related work experience is required, or an advanced degree with a minimum of 6 years of work experience. Project and portfolio management certificate or expertise is also needed.

What project management tools should I know for this position?

Expertise in Smartsheets or MS Project is required, along with experience developing and maintaining dashboards.

What is the company culture like at Dyne Therapeutics?

The role involves championing a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement, and collaboration.

What makes a strong candidate for this Director role?

Candidates with experience managing complex schedules in dynamic biotech environments, strategic thinking, result-orientation, and the ability to influence across functions like CMC, Quality, and Regulatory Affairs stand out. Experience in all phases of CMC regulatory submissions including IND, BLA, and post-approval changes is highly valued.

Dyno Therapeutics

Develops AI-optimized gene therapy vectors

About Dyno Therapeutics

Dyno Therapeutics focuses on advancing gene therapy by utilizing Artificial Intelligence to create Adeno-associated virus (AAV) vectors. These vectors are essential tools for delivering genetic material into cells, which is crucial for effective gene therapy. The company's AI technology enables the design and optimization of these vectors, potentially enhancing the success of gene therapies. Dyno collaborates with major pharmaceutical and biotech companies, such as Astellas, Roche, Sarepta, and Novartis, to develop therapies for various diseases affecting the skeletal and cardiac muscles, central nervous system, liver, and eyes. Unlike many competitors, Dyno's unique approach leverages AI to improve the performance of AAV vectors, setting it apart in the biotech field. The company's goal is to improve gene therapy outcomes through its advanced vector technology, ultimately benefiting patients with serious health conditions.

Watertown, MassachusettsHeadquarters

2018Year Founded

$106MTotal Funding

SERIES_ACompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Remote Work Options

Risks

Gene therapy investment slowdown may impact Dyno's growth and innovation.

Manufacturing bottlenecks could hinder scaling of Dyno's operations.

Increased competition from companies like Form Bio challenges Dyno's market position.

Differentiation

Dyno uses AI to design optimized AAV vectors for gene therapy.

Their AI-driven CapsidMap platform enhances AAV vector development for muscle gene therapies.

Partnerships with major pharma companies like Astellas and Roche boost Dyno's market presence.

Upsides

AI-driven capsid design improves delivery efficiency and reduces manufacturing costs.

Collaboration with NVIDIA enhances biological sequence design for gene therapies.

Generative AI increases efficiency of eye and brain-targeted capsid delivery significantly.

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