External Manufacturing Associate Director (Person In Plant)

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: March 19, 2023

Job Description:

External Manufacturing Associate Director (Person In Plant) page is loaded External Manufacturing Associate Director (Person In Plant) Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-18425 Job DescriptionThe primary focus of the Associate Director, External Manufacturing role is to oversee operations of Vertex's external commercial partner for the manufacture of small molecule Drug Product utilizing a continuous manufacturing platform, working in the newly formed External Manufacturing Operations team. 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 either at the Continuous Manufacturing CDMO site(s) and/or be able to travel to those sites routinely as a "Person-in-Plant". - Managing the external manufacturing network is a critical component of the 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 the external partner. 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 Product (manufactured on our continuous manufacturing rig). 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) including leader of the CDMO VPT/working team and strategic business review chairperson.
• Responsible for driving execution of the Trikafta DP production plan: 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. -
• 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, 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 Product 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. -
  • 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 expresses 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%#LI-KO1#LI-RemoteCompany 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. Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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. Similar Jobs (5) External Manufacturing Senior Director, Cell and Genetic Therapies locations Boston, MA time type Full time posted on Posted 30+ Days Ago Associate Director, External GMP QA Operations Cell and Gene locations Boston, MA time type Full time posted on Posted 8 Days Ago About Us Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) - a rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune's Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com -or follow us on Facebook , - Twitter , - LinkedIn , - YouTube -and - Instagram . The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives. -Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work. ALERT: If you have signed up for Job Alerts, please be aware that Job Alert Matches are currently not working. During this time, please check our careers site regularly for all open opportunities. We apologize for this systems issue and hope for it to be resolved soon.

Keywords: Vertex Pharmaceuticals, Boston , External Manufacturing Associate Director (Person In Plant), Professions , Boston, Massachusetts