R&D Formulation Scientist I

DESCRIPTION

• 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

QUALIFICATIONS

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.

Please apply at https://www.americanregent.com/Careers using Req. ID 102819.

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.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, Talent Acquisition Director at jrossini@americanregent.com.

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, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.