R&D Associate Scientist II

Nature and Scope

Responsible for formulation and process development activities associated with parenteral drug product development. Participates in scale-up of manufacturing process.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

• Conduct laboratory experiments with minimal supervision to support formulation and process development of injectables Execute laboratory studies for characterization, stability studies per ICH guidelines, component selection and scale-up activities Execute and support the formulation team on experiments to support the selection of process parameters and development of manufacturing process.
• Prepare formulations to support analytical method development.
• Draft protocols/reports on the formulation development experiments and deliver data presentations.
• Assist in the general operation of the R & D formulation laboratory including maintenance of Standard Operating Procedures (SOPs) and equipment validation or maintenance.
• Maintain clean and safe work environment in the laboratory.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health & 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.

• B.S. in Pharmaceutical Science, Chemistry, Chemical Engineering or equivalent required.
• 2-3 years, or for M.S. 0-2 year, of experience in drug product development required.
• Hands on skills in analytical instrumentals such as HPLC, particle sizer and Karl Fisher titrator is a plus.
• Excellent organizational, interpersonal and communication skills required.
• Proficiency in Microsoft Office Word and Excel is required.
• Ability to work overtime as needed.

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 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• 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.

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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