Associate Director, Drug Product Commercial Manufacturing (Small Molecules) - #19503907
Vertex Pharmaceuticals, Inc
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.
- 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
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.