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External Manufacturing Senior Manager (Small Molecule Drug Product)

Semma Therapeutics

Semma Therapeutics

Product
Boston, MA, USA
Posted on Saturday, May 18, 2024

Job Description

The Senior Manager of External Manufacturing will drive manufacturing operations and execution at Vertex’s external commercial partner(s) for the manufacture of Small Molecule Drug Product, while contributing to the broader External Manufacturing group activities. This is a Boston based, hybrid role (3 days/week onsite) with travel to CDMO sites as necessary (up to 75% travel)

Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain (CMSC) team’s role in ensuring that Vertex effectively and efficiently delivers medicines to patients. As such, we are looking for a leader to provide leadership, and both strategic and enterprise thinking in the management of the external partner. The candidate should have broad professional experience and the drive to work with both internal and external stakeholders to define and manage the execution of ongoing cGMP manufacturing of Drug Product supplies. This leader should have a strong operational, quality, compliance and technical background, 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), building and maintaining strategic relationships within the CDMO organization.
  • Responsible for driving execution of Drug Product 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 when required, 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 issue and increase productivity.
  • Partners with Tech Ops, Quality and CMSC Strategy and Business Operations to champion a culture of quality with our CDMO’s and to ensure that all activities and documentation comply with regulatory requirements.
  • Establish a robust tracking and reporting process to monitor CDMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
  • Leads identification and resolution of business-critical and contract issues; leading escalations to CMSC and Quality leadership.
  • 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.

Minimum Education and Experience:

  • BS/BA degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline
  • Requires 8 years or more of relevant experience in biotech/pharmaceutical industry.
  • Understanding of the science and technology underlying Small Molecule Drug Product manufacturing as well as analytical techniques that support commercial manufacturing activities.
  • Demonstrated understanding of the technical aspects of manufacturing, testing, and controls; engineering; plant operations; the regulations governing pharmaceutical operations, as well as financial systems and controls.
  • Strong quality and compliance background in a commercial GMP operational environment
  • 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.
  • Excellent communication and interpersonal skills with the ability to build 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 both internally and externally.
  • 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.
  • 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 hours required to cover critical process steps and troubleshooting.
  • Ability to travel, national and international, up to 50 - 75%.

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.