Director, IT Validation at Dyno Therapeutics

Waltham, Massachusetts, United States

Apply Now

Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor's degree in computer science, Information Technology, engineering or related field (advanced degree preferred)
Minimum of 10 years of experience in IT validation, including three years in a leadership role with GXP regulated environments
In-depth knowledge of FDA regulations, including 21 CFR Part 11, GAMP 5 and other relevant global regulatory requirements
Experience with validation of cloud-based systems and platforms in AWS
Proven ability to manage multiple validation projects in a fast-paced environment
Strong leadership skills with experience in mentoring and developing high performing teams
Excellent verbal and written communication skills with the ability to effectively communicate with stakeholders at all levels of the organization
Experience in managing validation activities during internal and external audits
Experience managing evidence collection and dissemination for assessments and audits
Excellent analytical and problem-solving skills
Ability to thrive in a fast-paced and dynamic environment
Outstanding vendor management skills

Responsibilities

Lead the development, planning, and execution of IT validation strategies for GxP systems, ensuring compliance with industry standards such as 21 CFR Part 11, GAMP 5, and other relevant regulations
Oversee the creation and review of validation documentation, including validation plans, protocols (IQ, OQ, PQ), risk assessments, and traceability matrices
Ensure IT systems are maintained in a validated state throughout their life cycle, including upgrades, patches, and decommissioning activities; collaborate with cross-functional teams (e.g., Quality, Regulatory, IT, and Operations) to ensure systems meet business needs and regulatory requirements
Serve as the subject matter expert on IT Validation—providing guidance and training to project teams and stakeholders
Manage and mentor a team of validation engineers and specialists, ensuring best practices are followed
Lead internal and external audits related to IT validation and compliance, preparing responses and driving corrective actions
Maintain up-to-date knowledge of global regulatory requirements, validation methodologies, and industry trends, and implement continuous improvement initiatives
Partner with vendors and consultants to ensure external systems and applications are validated in accordance with company policies; provide oversight of validation efforts for cloud-based systems and applications, ensuring compliance with GXP requirements

Skills

IT Validation

GxP

21 CFR Part 11

GAMP 5

Risk Assessments

Traceability Matrices

FDA Regulations

EMA Regulations

SOX Compliance

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.

Land your dream remote job 3x faster with AI

Try Jobo Free