Director, Process Analytical Technologies

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: April 30, 2024

Job Description:

Director, Process Analytical Technologies page is loaded Director, Process Analytical Technologies Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-21473 Job DescriptionThe Director of PAT has central responsibility for global, virtual manufacturingoperations in a technical area, overseeing activities of staff and adapting personnel deployment to changing priorities. The Director champions continuous improvement of activities and relationships within and outside Vertex. The Director takes a leadership role in company-wide initiatives and guides resolution of critical issues impacting manufacturing operations.KEY RESPONSIBILITIES:

• Spectroscopic method validation/implementation/revalidation and model maintenance (in house and working with CMO/CRO)
• Spectroscopic method development (NIR, Mid-IR, Raman, laser diffraction, acoustics)
• Experimental design to support new product commercialization and root cause analysis for existing products
• On-going support of commercial manufacturing activities utilizing continuous manufacturing processes and real-time release testing
• Data collection, multivariate data analysis for spectroscopy/process data, data interpretation, trending, and report generation
• Method transfers to new CMOs and analytical support for second-source activities
• Supporting new product development and commercialization and problem-solving/root cause analysis
• Authoring, reviewing, and approving technical documentation, including reports, protocols, work instructions, SOPs, etc.
• Understanding of physical characterization method development (XRPD, laser diffraction, vision analysis, powder flow analysis, etc.)
• Assist with troubleshooting pharmaceutical manufacturing operations and online PAT measurements in commercial manufacturing
• Assist with and lead resolution of quality investigations
• Work with supervisor to develop tools and standards for department functions
• Ensure positive and effective relationships between Vertex and key suppliers of materials, technology, and manufacturing resources
• Independently represent Tech Ops on cross-functional CMC sub-teams
• Responsible for overall relationship with contract manufacturing partners; provides leadership for the working team
• Drive best practices for trend analysis and continuous process improvement
• Determine project assignments and staffing requirements for projects
• Assist in setting overall strategy for technical area and creation of department goals
• Takes full responsibility within scope of the position to work with groups such as Quality, Supply Ops, Regulatory, Pharm Dev, suppliers, etc. to proactively resolve issues that may negatively impact project timelines or deliverablesTECHNICAL AND COMMUNICATION SKILLS:
  • Excellent interpersonal and collaboration skills
  • Knowledge of cGMP's and associated CMC regulatory considerations in a pharmaceutical environment
  • Proven ability to interact effectively and give presentations to senior management
  • Demonstrated flexibility to accommodate changes in responsibilities or project priorities
  • Expert knowledge of cGMP's and associated CMC regulatory considerations in a pharmaceutical environment
  • Proven ability to lead and manage projects of high complexity including development of and adherence to timelines and budget
  • Fosters a team environment of confidence and commitment and models the core values throughout the organization
  • Has achieved distinction in resolving important organizational problems using innovative approaches
  • Knowledgeable in technical areas outside main area of expertise
  • Proven supervisory experience and track record of enabling career development of staff
  • Bachelors and/or Masters degree and 10+yrs of relevant experience.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. 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 approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases - cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia - and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .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, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com -or follow us on Facebook , Twitter/X , - 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.
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Keywords: Vertex Pharmaceuticals, Salem , Director, Process Analytical Technologies, Executive , Boston, Massachusetts