Nature and Scope The Process Development Engineer Lead will work closely with the manufacturing, and quality department to develop process for new equipment, improve existing process for safety, reliability, and efficiency inside and outside the clean room. 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. Lead the process development of pharmaceutical drug product and oversee manufacturing activities within a cleanroom environment. Plan and prepare process equipment skid setup for manufacturing processes. Exercise critical thinking in investigation and troubleshooting experiments and process developments. Schedule manufacturing campaigns and process qualifications around deadlines. Initiate and update SOPs and other documents to ensure cGMP compliance. Review and approve batch records and process qualifications. Comply with and ensure all staff are practicing all safety policies and procedures. Tracks metrics to discover areas for improvement and monitor upgrades. Track equipment function and reliability. Communicates findings and proposals to upper management. Draft SOPs, forms, and other technical documents to ensure cGMP compliance. Utilizes process simulation software to test and find the most appropriate production strategies. 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. Bachelor’s or master’s degree in a STEM field. 2 or more years of pharmaceutical manufacturing experience required. Must have knowledge of cGMP and should have necessary skills working in controlled environments. Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis. Must have knowledge of concepts, procedures, and equipment common in pharmaceutical manufacturing. Ability to multi-task and retain flexibility in a dynamic environment. Well-developed written and oral communication skills. Demonstrate good management skills. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Physical Environment and Requirements Physically able to wear cleanroom/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. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. Employee is required to bend, sit, walk, work in noisy environments, able to work in small, and in unconditioned spaces. Expected Salary Range: $89,100-$100,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. 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. 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 email hrtalentacquisition@americanregent.com. 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 Pennsylvania and sales territories nationwide.