Process Engineering Director (Parenterals)

Job Description

General Summary:

Vertex Pharmaceuticals creates new possibilities in medicine to cure diseases and improve people’s lives. This Director, Manufacturing Science & Technology (MS&T) – Drug Product (Parenteral) opening is an exciting opportunity to join Vertex’s growing MS&T team and play a critical role in the rapid commercialization of new life-changing products in an innovative, high-science, Quality-by-Design, virtual manufacturing environment. If you are looking for an entrepreneurial, non-hierarchical, science-driven, collaborative environment where you can have a highly visible impact, then this is the perfect position for you!

The Director and his/her group partner with late-stage product development teams and contribute to regulatory filing activities to ensure the robustness of the process for parenteral drug product in a commercial setting, and to maximize benefits derived from an advanced Quality-by-Design approach. The 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 to drive continuous improvement initiatives in a global, post-approval environment.

In order to assure success in this role, the candidate must be an excellent communicator with proven experience in a cGMP pharmaceutical environment while bringing creativity and energy to all teams in order to promote positive, collaborative, and effective relationships with internal stakeholders and key external suppliers.

Key Duties and Responsibilities:

• Provide scientific expertise and technical guidance on parenteral drug product manufacturing processes, including formulation development, filling and finishing operations, and aseptic techniques. 
• Lead process validation and manufacturing activities for both small molecule & biologics parenteral products across a global supplier network
• Represent MS&T in leadership forums to influence late-stage product development and regulatory submission strategies for new parenteral drug products, ensuring high quality and consistent output, minimize commercialization risks, and foster effective post-approval and lifecycle management approaches while building strong relationships with key stakeholders.
• Partner with Pharmaceutical Development, Supply Chain, Quality and Regulatory to define technical transfer strategies which enable process validation and commercial manufacturing of Vertex products at new suppliers and new manufacturing sites.
• Ensure all manufacturing activities adhere to relevant regulatory requirements (FDA, EMA) for parenteral drug products, including quality standards, batch record review, and deviation management.
• Provides leadership to resolve critical issues impacting manufacturing operations in collaboration with relevant stakeholders
• Collaborate with Quality Assurance to monitor and address quality issues, investigate process deviations, and implement corrective actions. 
• Designs and implements functional/department goals and participates in setting goals for the overall division
• Participates in shaping technical direction of department and influences support of technological innovation and creativity
• Utilize data analytics to identify opportunities for process improvement, cost reduction, and yield enhancement. 
• Drive risk management and champions effective ongoing continuous improvement of manufacturing operations
• Determines hiring plan for the group in conjunction with Senior Management. Recruits, directs, motivates, and develops staff, maximizing their individual contribution, professional growth and their ability to build and sustain a team culture of efficiency and quality

Knowledge and Skills:

• Extensive experience in parenteral drug product development and manufacturing, including aseptic processing 
• Experience with process validation, technology transfer, and quality system management 
• Advanced knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical environment
• Expertise in pre-filled syringe combination product development, including device design, drug formulation, and packaging
• Deep understanding of regulatory requirements for combination products, including design controls and quality standards 
• Strong knowledge across multiple technical areas
• Strong communication, collaboration and team building skills; ability to connect with all levels of the organization
• Strong aptitude for motivating others and building team unity
• Proven ability to manage multiple high-priority projects with high degree of effectiveness
• Ability to navigate and be successful in a fast-paced, strong-matrix work environment
• Ability to travel domestically and internationally. (Approximately 30%)

Education and Experience:

• Bachelor's degree in pharmaceutical sciences or engineering discipline.
• PhD and 9+ years, or Master's and 12+ years, or Bachelor's and 15+ years of relevant work experience
• Knowledge of advance QbD concepts and experiences in applying QbD concepts, methodology and implementation to manufacturing processes for commercial products
• Strong knowledge of DoE and statistics

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

Company Information

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 [email protected]