Silexion is hiring!

Vice President, Pharmaceutical Operations (CMC)

We are seeking an experienced Vice President of Pharmaceutical Operations to lead our Chemistry, Manufacturing, and Controls (CMC) organization, with a specific focus on aseptic drug manufacturing and RNA therapeutics.

This senior leadership position will be responsible for driving technical and operational excellence across our manufacturing operations while ensuring regulatory compliance and quality standards.

## Key Responsibilities

* Provide strategic leadership for all CMC operations, including process development, technology transfer, and commercial manufacturing

* Lead and oversee aseptic manufacturing processes for RNA-based therapeutics and other complex biological products

* Direct the development and implementation of CMC strategies for pipeline products from early-phase development through commercialization

* Ensure compliance with cGMP requirements and other regulatory standards across all manufacturing operations

* Build and manage relationships with CDMOs and other strategic partners

* Lead and develop a high-performing technical team while fostering a culture of innovation and continuous improvement

* Collaborate with Research & Development to ensure seamless translation of products from research to manufacturing

* Oversee budget management and resource allocation for CMC operations

* Interface with regulatory authorities regarding CMC matters

## Required Qualifications

* Education in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field

* 15+ years of progressive experience in pharmaceutical manufacturing, with at least 8 years in senior leadership roles

* Extensive experience in aseptic processing and sterile manufacturing of biological products

* Demonstrated expertise in RNA therapeutics manufacturing and process development

* Strong track record of successful regulatory interactions and inspections

* Deep understanding of global regulatory requirements for CMC

* Experience with tech transfer and CDMO management

* Proven ability to build and lead high-performing technical teams

## Preferred Qualifications

* Knowledge of novel delivery technologies for RNA therapeutics

* Knowledge of Extended-Release technologies

* Experience with facility design and qualification

* Track record of successful commercial product launches

* Experience with quality by design (QbD) principles

* Six Sigma certification or similar process improvement expertise

## Leadership Competencies

* Strategic thinking and decision-making capabilities

* Excellence in project and program management

* Strong interpersonal and communication skills

* Ability to influence and lead cross-functional teams

* Problem-solving and analytical skills

* Change management expertise

## Key Performance Areas

* Manufacturing process optimization and efficiency

* Product quality and compliance metrics

* Timeline adherence for development programs

* Budget management and cost control

* Team development and retention

* Strategic partnership management

## Working Conditions

* May require travel (20-30%)

* Potential for international travel for CDMO oversight

## We Offer

* Competitive compensation package

* Comprehensive benefits

* Professional development opportunities