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Tracking # 52 Industry Pharmaceutical Jobs Job Title Process Development Scientist Location Raleigh, NC Salary Open Job Description ORAL SOLID DOSAGE (GRANULATION (HIGH SHEAR), COMPRESSION, COATING A MUST; WURSTER EXPERIENCE A PLUS The process development scientist is directly responsible for the management and execution of Commercial Product support projects in the areas of product technical transfer, process improvement and optimization, scale-up, troubleshooting, and investigation support. Identifies and evaluates critical process parameters. Conducts studies, write protocols and reports in support of process validation activities. Designs, develops, and conduct studies to produce robust bio-equivalent formulations and processes. Conducts analyses, writes reports to support filings, scale-up scientific papers and justification for changing processes. Responsible for transferring to Process Validation a robust, validable formula and process to meet requirements of the Code of Federal Regulations. Assists in development of process validation strategy for newly identified critical steps. Documents samples and test results. RESPONSIBILITIES •Leads multiple projects for troubleshooting, process optimization and technical transfer activities. Provides direction to lower-level staff members. Viewed as technical resource in process development, troubleshooting, process optimization, and scale-up. Reviews the work of less experienced resources and resolves problems. Establishes procedures and specifications. Writes and reviews reports and regulatory documents. Utilize statistical experimental design techniques. •Performs root cause identification of product related investigations. Manages alternate source projects for Active Pharmaceutical Ingredients (API’s). Performs troubleshooting activities for daily support of manufacturing relating to process and equipment. •Leads product transfer projects, transferring specific products to regular production at local site from an alternate manufacturing site or from on-site Product Development function. •Provides assistance/guidance to lower level scientists and technical staff. •Provides off-hour on-call support to manufacturing. •Documents findings, authors reports and regulatory documents. •Requires significant interaction with other functional groups within the site. •Works under limited supervision of management and/or teams leads. •Understands company goals and objectives and applies them when resolving a variety of problems •Uses judgment, creativity and sound technical knowledge to obtain and recommend solutions Interfaces with senior management to provide and obtain information. Possesses working knowledge of statistical analyses techniques for process control and data analyses. Possesses applied knowledge of analyses of critical process steps. Project Management Skills; Possesses applied knowledge of root cause analysis and troubleshooting techniques; Ability to utilize statistical experimental design techniques Minimum BS degree in scientific, engineering or life sciences area. 6-10 years with BS; 3-6 years with MS Relocation Package No Interview Expenses Yes Benefits Package Yes