External Manufacturing Associate Director

Job Description

General Summary:

Clinical & Commercial External Manufacturing Associate Director

The primary focus of the Associate Director, External Manufacturing role is to oversee operations of Vertex's external commercial partners for the manufacture of Biologics Drug Substance. The incumbent will lead the internal Virtual Plant Team (VPT) that oversee operations at the CDMO and co-lead joint project teams with the CDMO, while contributing to the broader External Manufacturing group activities. The candidate will be located in Boston or Seattle and be willing and able to travel to supplier sites routinely for oversight.

Managing the external manufacturing network is a critical component of the Clinical and Commercial Manufacturing and Supply Chain team's role in ensuring that the company effectively and efficiently delivers medicines to patients. As such, we are looking for a leader to provide vision, leadership, and both strategic and enterprise thinking in the management of external partners. The candidate should have broad professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of Drug Substance.This leader should have a strong operational, quality, compliance and technical acumen, with proven project management and supplier management abilities. They should have the ability to cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.

Key Responsibilities:

• Acts as main point of contact for CDMO(s) including leader of the CDMO VPT/working team and strategic business review chairperson.
• Responsible for driving execution of drug substance production plans: Provide operational oversight, and troubleshooting support, to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management).
• Maintain on-site presence acting as the Person-in-Plant at the CDMO facility and be Vertex's eyes and ears to ensure flawless execution of commercial operations. This may include some off-hours/days to resolve urgent issues.
• Lead continuous improvement initiatives to affect timely resolution of supply issues.
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
• Partners with Tech Ops, Quality and CMSC Strategy and Business Operations champion a culture of quality with our CDMO's and to ensure that all activities and documentation comply with regulatory requirements.
• Participate in the development of standard KPI's (Key Performance Indicators) and Monitor CMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
• Responsible for Long Term Strategic supplier management and accountable for Supplier Relationship Management (SRM) and SRM related processes for given CDMO.
• Leads identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy + Bus Ops, and Strategic Sourcing).
• Partners with Global Supply Chain to develop long-term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network.
• Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement.

Education and Experience:

• BS/BA degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline
• 8+ years of related experience of the equivalent combination of education and experience with 5 years relevant experience in biotech/pharmaceutical industry
• Understanding of the science and technology underlying Drug Substance manufacturing as well as analytical techniques that support commercial manufacturing activities.
• Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, maintenance, and engineering.
• Strong knowledge of cGMP requirements.
• A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
• Understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls and basic contract terms and conditions.
• Excellent communication and interpersonal skills with the ability to work in strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor.
• Excellent team player and be able to build and sustain organization respect and trust at all levels.
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them.
• Resilient and able to work well in a demanding, fast paced entrepreneurial environment.
• Sound judgment and business acumen with personal versatility and flexibility as business and team evolve.
• Keeps current on professional knowledge, expertise and best practices.
• Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Flexibility to work shift hours required to cover critical process steps and troubleshooting.
• Ability to travel, national and international, up to 50%

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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 ApplicationAssistance@vrtx.com