Senior Architect overseeing DevSecOps Platform Transformation at Travelers. Building relationships across engineering teams and advocating for technical direction with a focus on AI - powered solutions.
About the role
- Advisor for Technology Transfer & Process Engineering at Verve Therapeutics. Integrating technical operations in the development of gene editing medicines for heart disease.
Responsibilities
- have an integral role in Technical Operations contributing to tech transfer and manufacturing of Verve’s novel gene editing products
- facilitate drug product tech transfer efforts and drive successful clinical manufacturing by external vendors
- drive technical readiness and on-site support for manufactures of mRNA and gRNA across early-stage and late-stage programs
- includes batch record writing and executed record review, process scale-up, process data trending and support of quality activities including change controls, deviation investigations, implementation of process improvements
- oversee the manufacturing campaigns (on-site) at the CMO, including troubleshooting in close cooperation with the CMO and internal stakeholders
- lead transfer efforts of active clinical processes to secondary vendors to drive supply chain robustness
- coordinate with Supply Chain on sourcing key components and raw materials to support a complex global drug product manufacturing network
- collaborate with cross-functional teams including Process Development, Formulation, Preclinical Toxicology, Analytical Development, Quality Control, Quality Affairs, and External Manufacturing
- write and provide technical review of GMP documents including tech transfer reports, best practices documents, SOPs, technical protocols, manufacturing batch records, campaign summary reports, etc.
- write technical reports and contribute to global regulatory filings to support clinical development of Verve’s products
Requirements
- MS in engineering or related scientific field with 10+ years' relevant industry experience
- Strong process chromatography experience required, across multiple modes of separation, column formats, scale-up, chromatography equipment, and column qualification
- Gap assessment, relationship management, and organizational planning skills required
- Ability to clearly communicate risks and potential impacts to both peer groups and management
- Knowledge of GMP compliance around drug substance and drug product manufacturing
- Understanding of differences in requirements between early-stage and late-stage programs
- Attention to detail, critical analysis of data/reports, and troubleshooting abilities
- Proven ability to take initiative to achieve results, keep projects on timeline, and find solutions as needed to ensure that project deliverables are met
- Domestic and international travel required (25%)
Benefits
- eligibility to participate in a company-sponsored 401(k)
- pension
- vacation benefits
- eligibility for medical, dental, vision and prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance and death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Senior Engineer providing technical support for Carolinas Dispatchable Generation Stations within Duke Energy. Responsibilities include project implementation, controls support, and technical resource management in engineering specialization.
Senior Associate Developer responsible for designing and developing integration solutions for State Street's high - volume middleware platform. Collaborating within a diverse team to enhance enterprise integration capabilities.
Software Development Analyst at Northrop Grumman supporting Product Lifecycle Management systems. Collaborating across functional teams while providing user support in a technology - driven environment.
Engineering Technician IV providing professional technical support to engineers in research and development. Involves hands - on tasks with electrical, electronic, and mechanical components.
Deep Learning Algorithm Developer developing perception technologies for autonomous driving in real - world environments. Tackling challenges from object detection to 3D perception using state - of - the - art deep learning models.
Senior Manager Engineering Projects at Amgen, managing global capital planning and continuous improvement initiatives for innovative biopharmaceutical solutions.
C#.Net Developer responsible for creating software applications. Involves working with various technologies including C#.NET, MVC, .Net Core, and Microservices.
CNC Programmer responsible for preparing NC programs for milling aerospace components using advanced technologies. Working with cutting tools and machining steel and aluminum at Expleo.
SPS Programmierer at Werner & Pfleiderer developing and optimizing control technology programs using TIA Portal. Collaborating with teams to improve technical product information and ensure machine efficiency.