American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
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.
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.
- Conduct the experiments under the supervision of Scientists for Tech Transfer, Process R&D/Scale up/Validation, and other activities needed for introduction of a new product into cGMP manufacturing site or to support process improvements of existing products.
- Execute laboratory experiments as per the protocols or under supervision to study material compatibility studies and/or cleaning validation activities
- 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.
Qualifications and Requirements
- Master’s Degree in Chemical Engineering or Pharmaceutical Chemistry with 0-1 years’ experience or Bachelor’s Degree with 1-2 years’ progressive work experience in Technical Services encompassing Tech Transfer, Technical Trouble shooting, and process optimization
- Knowledge/ Experience in Process Development and scale up of sterile injectable products is beneficial.
- Hands on skills in Laboratory instruments such as particle sizer, HPLC, Karl Fisher, DSC, etc.
- Knowledge of pharmaceutical 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 Physical 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.
- 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.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.