Nature and Scope:

This R&D position will be responsible for leading the project from feasibility phase to commercial launch.

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 development, optimization and validation activities of analytical methods for multiple projects simultaneously.
• Analyze and review project data and report for multiple projects in support of research and development for small molecule, polymer, peptides etc.
• Lead Extractable and Leachable test design and execution, perform leachable risk assessment on manufacturing components and container closure system.
• Plan and execute requisite lab work to answer FDA deficiency questions/Complete Response Letter for submitted ANDA. Draft control correspondence or pre-development meeting request.
• Design investigation plans for challenging technical questions for complex injectable product development. Drive the discussion with Regulatory Affairs, Quality Assurance to align on critical quality attributes, test methods, specifications and risk evaluations.
• Communicate and oversee contract laboratory development activities and provide technical support. * Author and review scientific and regulatory documents for filing support.
• Document findings, work on closing open investigations (deviations, OOS etc) and write standard[1]operating procedures (SOPs).
• Mentor junior level scientists and chemists on method development, instrument troubleshooting and investigations.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, 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.

• Master's Degree with minimum 10 years or Ph.D. with minimum 5 years of Pharmaceutical industry experience in method development and validation required.
• Demonstrated expertise with HPLC, GC, IC, LC-MS, dissolution instrumentations.
• Previous experience in one or more of the following areas is strongly preferred, extractable/leachable testing, complex injectable product development, peptide/oligonucleotide characterization.
• Experience managing multiple projects simultaneously.
• Strong technical writing skills required.
• Excellent organizational, interpersonal and communication skills (oral and written). * Proficiency in Microsoft Office word and excel required.
• Familiar with ICH, FDA, and USP guidance.

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.
• Position requires working in the laboratory as well as sitting.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

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.

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