Scientist - Formulation R&D - United States
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- Our company is looking to expand its Formulation R&D team by adding a Scientist at their US Headquarters.
- The Scientist will support development and commercialization of new or reformulated products by designing and documenting formulations which meet the company’s First-to-File and First-to-Market strategy.
Major duties and responsibilities to include:
- Provides support to (or may lead) product/process development and commercialization activities for new immediate release and modified release solid oral dosage, liquid oral dosage forms and semisolid topical dosage forms to facilitate “First-to-File” and “First-to-Market” corporate goals.
- Lead the manufacture of Pivotal/Registration lots for new products in the Product/Process Development Pilot Plant and Manufacturing facilities.
- Perform effective problem solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects.
- Generate accurate, reliable data by following established procedures and practices.
- Record, tabulate, summarize, interpret, report and publish study results. Prepare Master Batch Records for Experimental, Pilot/Pivotal, scale-up and process validation batches. Analyze and defend scientific results. With guidance, interpret in-vitro and in-vivo data to derive clear conclusions and recommend direction for future work. With guidance, prepare or co-author Product Development documents for inclusion into the eCTD and Quality Overall Summary (QOS).
- Hands-on formulation design, development and optimization with guidance as appropriate.
- Design and perform quality scientific experimentation. Contribute to the development of new experimental approaches. Design stability studies.
- May lead and/or Collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits.
- Maintain scientific currency. Acts as internal/external Subject Matter Expert (SME) for drug product and process related technical issues and provides technical support to Technical Operations, Manufacturing, Quality and to third party contractors.
- Ensure compliance with current Drug Enforcement Administration (DEA), current Good Manufacturing Practices (cGMP), company policies and Quality Systems, and all applicable regulatory agencies.
- Knowledge of the principals and practices of pharmaceutical sciences combined with professional experience in developing and testing formulation processes in more than one dosage form or product category.
- Sound problem solving skills and good scientific judgment are required.
- Good communication skills and the ability to work on interdisciplinary teams are required.
- Familiarity with project management methodology is necessary.
- Experience in Pellet/Particle/Bead Coating is highly preferred.
- These skills are normally acquired through completion of a Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with 4 to 6 years of research experience in the pharmaceutical industry, or a Master's degree combined with 2 to 4 years of relevant experience, or a Doctoral degree combined with relevant experience.