R&D Technical Services Scientist II

Nature and Scope

Responsible for Technology Transfer and process scale up activities associated with parenteral drug products. Supports cross-functional Production, Engineering, Quality Assurance, and Validation departments to support the trouble shooting of manufacturing issues. Support the ANDA submission activities and regulatory responses to FDA deficiency.

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.

• Design and execute the experiments for Tech Transfer, Process R&D/Scale up/Validation, and other activities needed to introduce a new product into cGMP manufacturing site.
• Work with Production, Engineering, Quality Assurance, and Validation departments for equipment qualification, process scale up, optimization, and validation.
• Work with R&D project leads and develop a robust technology transfer processes from lab scale to manufacturing site.
• Co-ordinate with CMOs for the external Technology Transfers (If required).
• Design and execute laboratory experiments to study material compatibility studies and/or cleaning validation activities.
• Support the Troubleshooting for existing processes and analytical methods.
• Evaluate vendor change notifications for raw materials, excipients and manufacturing materials against current specifications supporting cGMP manufacturing.
• Generate the documents in support of regulatory submissions.
• 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.

• Bachelor's Degree with 7-8 years' progressive work experience in Technical Services encompassing Tech Transfer, Technical Trouble shooting, and process optimization, required.
• Master's Degree in Chemical Engineering or Pharmaceutical Chemistry with 3-6 years' experience, preferred.
• Broad knowledge of Process development and scale up of sterile injectable products is essential.
• "Outside the box thinking" and Collaborative mindset is required.
• Hands on skills in Laboratory instruments such as particle sizer, HPLC, Karl Fisher, DSC, etc.
• Knowledge of pharmaceutical product development and 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.

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

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