Vertex Pharmaceuticals creates new possibilities in medicine to cure diseases and improve people's lives. The Associate Director, Drug Product Tech Transfer/Commercial Manufacturing is responsible for the successful tech transfer, validation, and commercial manufacturing of small molecule drug products in an innovative, high-science, Quality-by-Design, virtual manufacturing environment. If you are looking for a high impact technical leadership role in an industry-leading company producing important medicines, this is for you!
The Associate Director will partner with late-stage product development teams and contributes to regulatory filing activities in order to ensure the robustness of the drug product process in a commercial setting, and to maximize benefits derived from an advanced Quality-by-Design approach. The Associate Director is responsible for successful process validation and commercial manufacturing, drives resolution of complex manufacturing issues, and leads global expansion activities throughout the product lifecycle in a complex, global environment. The successful candidate will champion high-impact cross-functional initiatives and maintain strong relationships with key internal and external stakeholders. This role requires proven experience in a cGMP environment, a broad understanding of the interaction between technical, regulatory, and business challenges, and strong scientific/engineering skills in order to drive continuous improvement initiatives in a global, post-approval environment.
Key Responsibilities:
Ensure robustness of commercial processes for new products and line extensions through effective involvement in cross-functional late-stage development activities and regulatory filings
Lead drug product process validation and manufacturing activities for small molecule oral solid dosage forms and processes (batch and continuous) across a global supplier network
Resolve complex commercial manufacturing issues being mindful of Supply, Quality, and Regulatory constraints
Ensure ongoing production of timely, quality drug product by leading tech transfer, commercial manufacturing, technical support, and process monitoring/trending activities
Drive risk management and continuous improvement of manufacturing processes and of supporting business and quality systems
Provide strategic input to shape Technical Operations priorities and future growth
Supervise, develop, and recruit staff to support ongoing commercial manufacturing and process improvement initiatives
Minimum Qualifications :
PhD with 8+ years or BS/MS with 10+ years of relevant work experience
Advanced knowledge of cGMP's, associated CMC quality systems and regulatory considerations in a pharmaceutical setting
Experience in drug product manufacturing operations of oral solid and technical support
Demonstrated leadership, collaboration, and mentoring skills
Experience working with external contract manufacturing organizations (CMO)
Knowledge of advanced QbD concepts, and experience with their implementation for commercial products
Advanced knowledge of DoE and statistics
Expertise in continuous manufacturing, automation, PAT, and RTRT implementation