• Utilize your knowledge of scientific principles, theories, and concepts to develop solutions to moderate to high complexity problems. 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 an 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 advanced technologies for process evaluations and optimization, such as Process Analytical Technology, electronic batch records, etc.
• Review and provide inputs for validation master plans, validation protocols, validation reports, continued process verification (CPV) plans, statistical sampling plans, among other important strategic documents.
• Act as an 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. Expertise in the use/application of a variety of problem-solving tools, such as Ishikawa, Kepner-Tregoe (KT), five-whys, etc. and 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.

• Experience in cGMP manufacture of commercial or late phase clinical products, including experience with technology transfer and scale-up.
• Familiarity with statistical process control (SPC), complex data analysis, mathematical modeling, and optimization software (like MiniTab, JMP, etc.) is a must.
• Knowledge and experience in cGMP, risk assessment, and investigation tools and techniques.
• Able to work on multiple projects simultaneously. Familiarity with project management concepts is preferred.
• Proficiency with Quality by Design (QbD) concepts and design of experiments required.
• Demonstrated ability to provide scientific input and make decisions to resolve problems with minimal supervision.
• BS/MS/Ph.D. in pharmaceutical sciences/chemistry (or related field like organic, physical, biochemical, chemical engineering) with 6+ years (BS), 4+ years (MS), or 2 years (Ph.D.) industrial GMP experience.

Leveraging the power of relationship building and the Adecco brand, we work to align candidates with permanent positions based on skillset and job requirements. Our personal and tailored approach assures that our candidates are placed into positions that align with their long-term goals. We specialize in recruiting for permanent positions within the Life Sciences industry. Here are just some of the roles we specialize in: - Biotechnology - Pharmaceutical - Clinical Research/Trials - Medical Devices - Quality Assurance - Engineering