Luitpold Pharmaceuticals, Inc. R&D Technical Services Scientist in New Albany, Ohio
PharmaForce, Inc. is a pharmaceutical research, development and manufacturing company based in the Columbus, Ohio area specializing in the sterile injectable market. PharmaForce is wholly owned by parent company, Luitpold Pharmaceuticals, a division of Japanese pharmaceutical company Daiichi Sankyo. We are an Equal Opportunity Employer (Minority/Female/Veterans/Individuals with Disabilities).
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 the experiments for Tech Transfer, Process R&D/Scale up/Validation, and other activities needed to introduce a new product into cGMP manufacturing site.
Support the Troubleshooting for existing processes and analytical methods
Work with Production, Engineering, Quality Assurance, and Validation departments for equipment qualification, process scale up, optimization, and validation.
Co-ordinate with CMOs for the external Technology Transfers (If required)
Work with R&D project leads and develop a robust technology transfer processes from lab scale to manufacturing site.
Design and execute laboratory experiments to study material compatibility
Draft the Engineering Protocols, Technology Transfer reports, and Master Batch Records.
Generate the documents in support of regulatory submission.
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.
We all must embrace the QUALITY culture.
Qualifications and Requirements
Master’s Degree in Chemical Engineering or Pharmaceutical Chemistry with 2-5 years experience or Bachelor’s Degree with 5-8 years progressive work experience in Technical Services encompassing Tech Transfer, Technical Trouble shooting, and process optimization
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 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
While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
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.
Job Title: R&D Technical Services Scientist
Employment Type: Full Time
Date Posted: 10/12/2017
Requisition ID: 1809