Formulation Scientist

Scientist – Principal Scientist – Injectables Formulation

Pay: $95,000 - $115,000

SUMMARY

This leading global pharmaceutical company is looking for a strong Formulation Scientist to join their R&D team in support of one of the fastest growing portfolios of pharmaceutical drug products across a wide range of therapeutic areas. The ideal candidate will have at least 1-2 years of hands-on experience with parentals (injectables) and scale-up from lab scale to commercial manufacturing batches in a cGMP environment.

RESPONSIBILITIES

• Lead formulation development activities as the SME for sterile-injectables
• Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE).
• Conduct GMP stability studies & analysis using the relevant industry-standard modeling tools to ensure purity and shelf life of products throughout scale-up processes.
• Manage tech transfers to CRO/CDMO/CMO’s in collaboration with project management teams in accordance with project timelines & deliverables.
• Participate in cross functional meetings and provide input on strategy implementation for various projects.
• Author & review relevant technical documents/SOP’s & FDA submissions
• Mentor junior staff on formulation techniques

QUALIFICATIONS

• Masters in Pharmaceutical Sciences (Or equivalent/relevant degree) with 3-5 years of drug product/formulation experience in the pharma industry
• At least 1-2 years of experience with sterile injectables/parentals and scaling up to manufacturing-scale is a MUST.
• Strong communication skills (written & verbal)
• Prior experience with tech-transfers or management of CRO’s/CMO’s is a PLUS
• Experience with additional dosage forms (nasal, solid-oral, topical, solutions, etc.) is a major plus!

ADDITIONAL

• Fully on-site position
• Relocation & Sponsorship available
• 10-15% Annual Bonus + Strong Benefits Package