- Vertex Pharmaceuticals
- $64,605.00 -141,170.00/year*
Full-Time Job Description: Vertex?s Technical Operations Drug Product team has an exciting and challenging opportunity for you to facilitate rapid commercialization of new products utilizing traditional and continuous manufacturing technology in our industry-leading Quality by Design (QbD) environment. Vertex has three significant commercial products in addition to multiple new molecules in various stages of clinical development. The successful candidate will have the opportunity to add significant value in several areas: Process Validation and New Product LaunchDevelop and execute process validation strategies under quick timelines by working with cross-functional teams including formulation development, analytical, quality, supply chain and regulatory to ensure creative and efficient implementation.Formulate validation master plans, validation protocols, validation reports, continued process monitoring plans and statistical sampling plans, among other important strategic documents. Commercial ProductionSupport ongoing internal and external commercial manufacturing activitiesResolve complex commercial manufacturing issuesConduct commercial continued process monitoring and process improvements. This includes the opportunity to apply statistical process control to recognize data trends and then implement improvements. Technology TransferDirect technology transfer to enable both continuous and traditional manufacturing at external suppliers.Provide technical input to Supply Chain, Quality, and Regulatory to formulate global regulatory strategy for qualification of new manufacturing sites.The candidate must be an excellent collaborator and proven technical leader with experience in a cGMP pharmaceutical drug product manufacturing environment. The successful candidate will have a solid background in solid oral dosage form manufacturing. Experience with spray dried dispersion technology (and its related processes and unit operations) is a plus. Minimum Qualifications: Minimum Qualifications:Degree in a pharmaceutical science or engineering discipline: BS and 5 years, MS 3 years or PhD with 2 years of relevant work experienceExperience in cGMP manufacture of commercial or late phase clinical products. Experience with technology transfer and scale up is a plus.Process Development of solid oral dosage forms and a sound understanding of the pharmaceutical development process.Proven ability to solve complex technical and equipment qualification challenges using a rational, scientific approachProficiency with Quality by Design (QbD) concepts and design of experiments required.Familiarity with statistical process control (SPC), complex data analysis, mathematical modeling and optimization software (like Matlab, JMP, etc.) is a plus.Must be a committed team player and collaboratorDemonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environmentWillingness and Ability to travel up to 30% of the time.Preferred Qualifications:Experience with Process ValidationExperience with commercial manufacturing of biologics and/or parenteral products is a plus but not required. Company Information: Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry?s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit www.vrtx.com. 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 ApplicationAssistancevrtx.com. Req ID: 11555BR
Associated topics: biomechanics, biomedical, biophysics, fermentation, molecular, msat, neuroscience, pain, pathogenesis, pharmaceutical
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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