Nature and Scope Responsible for formulation and process development activities associated with parenteral drug product development following Quality by Design (QbD) principal. Participates in manufacturing process scale-up and technology transfer. Supports trouble shooting of manufacturing issues, ANDA submission and regulatory response to FDA deficiency. Responsible for training of laboratory personnel in areas of expertise. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Conduct 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 process for parenteral drug products. Draft raw material specifications. Write R & D study and product development reports and generate documents in support of regulatory submission. Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health and safety requirements. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. PhD with experience 5 years progressive work experience in pharmaceutical drug product development, or master’s degree plus 10 years progressive work experience in pharmaceutical drug product development required. Broad knowledge of formulation development following QbD principal, formulation characterization, process development, and scale up of sterile injectable products is essential. Experience in development of suspension and freeze dried products is a plus. Hands on skills in analytical instrumentals such as HPLC, particle sizer and Karl-Fischer titrator are a plus. Knowledge of pharmaceutical product lifecycle management is a plus. Excellent organizational, interpersonal and communication skills are required. Proficiency in Microsoft Office Word and Excel is required. Physical Environment and Requirements Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Position requires working in the laboratory as well as sitting. 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 Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. 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 [email protected]. Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.

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