Job Description:
Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
MS&T Scientist III
US-NJ-Lakewood
Job ID: 2024-2759
Type: Regular Full-Time
# of Openings: 1
Category: MS&T
Lakewood, NJ
Overview
MS&T Scientist III – Renaissance Lakewood, LLC, Lakewood, NJ.
Responsibilities
Utilize and apply knowledge of basic scientific principles, theories and concepts to develop solutions to problems of moderate to high complexity. Lead multidisciplinary teams in developing and implementing solutions. Perform site transfer activities to Renaissance from business partner locations and provide scientifically sound development reports. Develop and optimize manufacturing processes for clinical, registration, and commercial scale batches for sterile and non-sterile formulations. Prepare and review Master Batch Records for experimental/engineering, registration, scale-up, and process validation batches. Prepare robust pharmaceutical/process development reports and other CMC documentation for regulatory submissions and represent Renaissance as SME during internal/external regulatory audits. Use statistical process control and other statistical tools for comparison and hypothesis testing. Apply engineering, pharmaceutical sciences, or materials sciences fundamentals to model the product and process to solve complex technical problems. Evaluate and implement advance technologies for process evaluations and optimization (e.g., Process Analytical Technology, electronic batch records etc.) Review and provide inputs for validation master plans, validation protocols, validation reports, continued process verification (CPV) plans, and statistical sampling plans, among other important strategic documents. Act as internal/external Subject Matter Expert (SME) for drug product and process related technical issues and provide technical support to Formulation, Manufacturing, and Quality. Identify potential root causes of variation and deviations using a systematic approach. Utilize problem-solving tools including Ishikawa, Kepner-Tregoe (KT), and five-whys to lead technical Deviation write-ups and CAPA assignments. Work closely with the process engineering team to develop robust user requirement documents for process equipment including manufacturing and packaging. Provide technical input to the management team regarding site capacity to evaluate new projects. Lead and guide other scientists/associates in process development and manufacturing.
Qualifications
Bachelor’s degree, or foreign equivalent, in pharmaceutical sciences, chemistry, or a related field. 6 years of experience in job offered or similar role. 6 years of experience with/using Statistical Process Control (SPC), complex data analysis, MiniTab, cGMP, risk assessment and investigation tools, Quality by Design (QbD) concepts, Ishikawa, Kepner-Tregoe (KT), Five-whys, Deviation write-ups, CAPA assignments (experience may have been gained concurrently).
PI242970305
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