American Regent
Job Opportunity
Responsible for conducting literature search and pre-formulation studies on new generic products. Design and execute parenteral formulation studies in accordance with company procedures and appropriate FDA/ICH guidance. Design and execute laboratory experiments to study material compatibility and evaluate sterilization options. Develop scalable manufacturing processes for parenteral drug products. Write R&D study and product development reports and generate documents in support of regulatory submissions. Ensure work product is performed and documented in accordance with existing company policies, procedures, and health and safety requirements. Salary: $95,000 - $110,000 Master's Degree (or foreign equivalent) in Chemistry, Pharmaceutical Science or a related field, plus three (3) years of research and development experience in pharmaceutical or similarly regulated industry. In addition, three (3) years of experience with the following is required: Formulation development following Quality by Design (QbD) principal, formulation characterization, process development, and scale up of sterile injectable products. Analytical instrumentals, such as high-performance liquid chromatography (HPLC). Pharmaceutical product lifecycle management. Microsoft Office suite of products, particularly Microsoft Word and Excel, including advanced Excel functions: pivot tables, v-lookup, and macros. Due to day-to-day job requirements, upon hiring, individuals will be required to provide evidence of possessing 20/40 near vision (corrective lenses allowed) and must undergo Color Blindness Screening (D15). Must be physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves, as well as PPE and Respirators, which are essential for the health and safety of employees working in the laboratory. Domestic travel required to various unanticipated worksites approx. 10% of time. American Regent celebrates diversity, and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Responsible for conducting literature search and pre-formulation studies on new generic products. Design and execute parenteral formulation studies in accordance with company procedures and appropriate FDA/ICH guidance. Design and execute laboratory experiments to study material compatibility and evaluate sterilization options. Develop scalable manufacturing processes for parenteral drug products. Write R&D study and product development reports and generate documents in support of regulatory submissions. Ensure work product is performed and documented in accordance with existing company policies, procedures, and health and safety requirements. Salary: $95,000 - $110,000 Master's Degree (or foreign equivalent) in Chemistry, Pharmaceutical Science or a related field, plus three (3) years of research and development experience in pharmaceutical or similarly regulated industry. In addition, three (3) years of experience with the following is required: Formulation development following Quality by Design (QbD) principal, formulation characterization, process development, and scale up of sterile injectable products. Analytical instrumentals, such as high-performance liquid chromatography (HPLC). Pharmaceutical product lifecycle management. Microsoft Office suite of products, particularly Microsoft Word and Excel, including advanced Excel functions: pivot tables, v-lookup, and macros. Due to day-to-day job requirements, upon hiring, individuals will be required to provide evidence of possessing 20/40 near vision (corrective lenses allowed) and must undergo Color Blindness Screening (D15). Must be physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves, as well as PPE and Respirators, which are essential for the health and safety of employees working in the laboratory. Domestic travel required to various unanticipated worksites approx. 10% of time. American Regent celebrates diversity, and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.