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 drug product 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.
- 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 a broad range of products (small-molecule and biologics) and processes (batch and continuous) across a global supplier network
- 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
- Mentor and develop junior staff
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
- PhD with 6+ 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 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
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