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Process Engineering Senior Specialist

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: May 28, 2023

Job Description:

Process Engineering Senior Specialist page is loaded Process Engineering Senior Specialist Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-18729 Job DescriptionGeneral Summary:Vertex's Technical Operations Drug Product team is looking for a Process Engineering Senior Specialist for an exciting and challenging opportunity to facilitate rapid commercialization of new products utilizing traditional and continuous manufacturing technology in our industry-leading Quality by Design (QbD) environment.The Technical Operations Drug Product team is responsible for managing small molecule drug product from new product launch through commercial production. This involves commercial process validations, technology transfers as well as being accountable for routine commercial production.Vertex manages its portfolio of products using both internal and external manufacturing options meaning the position involves collaboration across different disciplines and organizations.Key Duties and Responsibilities:

  • Work with cross disciplinary teams to support the execution and documentation of key launch/tech transfer documents (VMP, VSR, PPQ protocol, PPQ report, etc.).
  • Collaborating with commercial manufacturing and quality to support ongoing qualification activities associated with maintaining a commercial product such as new material qualification.
  • Be an owner of a commercial product and be accountable for Change Controls, Deviations and CAPAs.
  • Participate in resolving complex commercial manuafcturing issues and quality investigations.
  • Drive the industry leading CPV programming by tracking/trending commercial production.
  • Support Tech Ops Drug Product team scope of work with external suppliers.
  • Will require periodic travel to control manuafcturing plants to monitor and/or troubleshoot processes.Knowledge and Skills:
    • Support commercial manufacturing operations at suppliers and assists in resolution of -quality investigations.
    • Understanding of principles and practice of cGMPs and associated CMC regulatory considerations in a pharmaceutical environment.
    • Effective written and verbal communication skills.
    • Ability to multitask to effectively manage multiple activities and projects.
    • Ability to collaborate with and communicate results to relevant stakeholders.
    • Willingness and ability to work in a fast-paced, highly matrixed environment.Preferred Knowledge and Skills
      • Experience with commercial manufacturing of spray dried dispersion and/or oral solid dosage forms.
      • Familiarity with complex data analysis, mathematical modeling, and optimization software (like Matlab, JMP, Statistica, etc.).
      • Knowledgeable in QbD and designed experiment methodology and implementation.Education and Experience: D eg r ee in a p h a rmac eu tica l s ci en c e or e n gin e e ri ng di s ci p li ne:
        • BS with 3+ years of experience, or
        • MS with 1+ years of experience, or
        • PhD with 0+ years of experienceCompany 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 Similar Jobs (5) Manufacturing Technical Investigations Senior Specialist locations Boston, MA time type Full time posted on Posted 30+ Days Ago Research Associate II, Process Development Engineering (Contract) locations Boston, MA time type Full time posted on Posted 30+ 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 -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 , Process Engineering Senior Specialist, Engineering , Boston, Massachusetts

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