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

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%)

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)