R&D Formulation Sr Scientist I

American Regent, Inc. • New Albany, OH

7d • Onsite

About The Position

Responsible for formulation and process development activities associated with parenteral drug product development following Quality by Design (QbD) principal. Participates in manufacturing process scale-up and technology transfer. Supports trouble shooting of manufacturing issues, ANDA submission and regulatory response to FDA deficiency. Responsible for training of laboratory personnel in areas of expertise.

Requirements

• PhD with experience 5 years progressive work experience in pharmaceutical drug product development, or master’s degree plus 10 years progressive work experience in pharmaceutical drug product development required.
• Broad knowledge of formulation development following QbD principal, formulation characterization, process development, and scale up of sterile injectable products is essential.
• Excellent organizational, interpersonal and communication skills are required.
• Proficiency in Microsoft Office Word and Excel is required.
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
• 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.

Nice To Haves

• Experience in development of suspension and freeze dried products is a plus.
• Hands on skills in analytical instrumentals such as HPLC, particle sizer and Karl-Fischer titrator are a plus.
• Knowledge of pharmaceutical product lifecycle management is a plus.

Responsibilities

• Conduct literature search and pre-formulation studies on new generic products.
• Design and execute parenteral formulation studies in accordance with company procedures and appropriate FDA/ICH guidance.
• Design and execute laboratory experiments to study material compatibility and evaluate sterilization options.
• Develop scalable manufacturing process for parenteral drug products.
• Draft raw material specifications.
• Write R & D study and product development reports and generate 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.
• Responsible for training of laboratory personnel in areas of expertise.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior