Nature and Scope:

This R&D position will be responsible for developing stability indicating methods and validation execution to support raw material and finished product evaluation and drug application filings with FDA.

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.

• Develop analytical methods for API and finished product characterization, such as assay, impurity, residual solvents, in vitro release method, extractable/leachable testing, molecular weight determination, particulate matter etc.
• Design and execute method validation protocol in accordance with American Regent procedures and FDA guidance. Support method transfer activities to Quality Control labs.
• Support activities with ANDA submission such as authoring product/method development reports, leachable report, and API/FP specifications. Support activities for FDA deficiency response, product complaints following company's compliance policies.
• Perform testing of samples as required to support product development, regulatory submission and the exhibit batch stability program. Perform laboratory work to support product or process troubleshooting and special investigations.
• Manage external analytical development activities through contracted research organizations (CROs).
• Assist in the general operation of the Research and Development analytical laboratory, including maintenance of Standard Operating Procedures (SOP's), training and equipment validation or maintenance.
• Maintain accurate and complete laboratory records as required by company policy and Good Manufacturing Practices (cGMP) 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 minimum 2 years or Master with minimum 5 years of pharmaceutical industry experience in method development and validation, or Bachelor's Degree plus 7 years progressive work experience required.
• Demonstrated expertise with HPLC, GC, IC, LC-MS, GC-MS and various detection techniques.
• Experience with one or more of the following areas is strongly preferred, complex injectable characterization, extractable/leachable testing, peptide and oligonucleotide characterization.
• Experience with Circular Dichroism, MALS, FTIR, bioassay development is a plus.
• Familiar with ICH, FDA and USP guidelines. * Excellent organizational, interpersonal and communication skills (oral and written).
• Proficiency in Microsoft Office word and excel 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.

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