Solid Dose Process Development ScientistABOUT THE ROLE AnazaoHealth is a 503B outsourcing facility in Las Vegas, Nevada. The Solid Dose Process Development Scientist will report to the Facilities and Engineering Manager in support of process development, scale up, and process validation. This role will work cross-functionally between Engineering, Production, and Quality and act as the team lead to ensure the timely and successful completion of projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, but other duties may be assigned:
Identify Critical Quality Attributes (CQAs) for solid dose product lines. Use statistical tools to assign analytical limits and assist Engineering in defining control strategies.Manage product process development through scale up and collaborate with the Validation team to complete process validation.Author and review GMP documentation related to process development (protocols, Design of Experiments (DOEs), SOPs, Change Controls).Identify key data collection points within production and create standard methods for collecting and analyzing.Monitor and routinely report on process performance in the form of periodic presentations.Provide budgets and timelines for new projects with regularly scheduled deliverables.Assist with verifying that all regulatory requirements set by governing bodies (FDA, EU, EPA, etc.) are met during the analytical and scale up work.Maintain a positive and professional attitude when working with team members.Provide technical support and expertise to other departments as needed.Note: The above statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities of an employee in this job. Job duties can change at any time as directed by management. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the employer. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
REQUIRED Bachelor of Science degree in Biotechnology, Biological or Pharmaceutical Sciences, or Engineering (chemical, biological, or biochemical).5 – 7 years of experience in a pharmaceutical GMP environment.Direct experience with solid dose manufacturing.Experience in preparing chemistry, manufacturing, and controls (CMC) data.A range of experience in process development, scale up, and/or production-level manufacturing.Proficient in Microsoft Office (Excel, Word, Access).Strong knowledge of statistics and statistical analysis platforms (Minitab, JMP).Strong technical writing skills.AnazaoHealth offers competitive salaries and a comprehensive benefits package to include 401(k), health insurance coverage for you and your dependents, paid holidays, PTO, and Volunteer Paid Time Off.
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