Sr. Scientist, Formulation Development

In this role you will advance OINDP formulation development from early stages through regulatory submission and launch, helping expand Hikma's inhalation portfolio. You will work within the OINDP formulation team to deliver technically rigorous studies, support regulatory filings, and drive scale-up and tech transfer with cross-functional partners. You will tackle challenging characterization, data analysis, and validation tasks that shape impactful, patient-focused products. This position offers a fast-paced environment with the opportunity to influence a growing platform and contribute to impactful therapies.

• Annual performance bonus
• 401(k) with company match
• PTO starting at 20 days
• 11 company paid holidays
• Comprehensive benefits (health, dental, vision)
• Tuition reimbursement

• Design and execute OINDP formulation development studies applying QbD principles
• Lead or contribute to CMC sections of regulatory dossiers (ANDA, NDA, 505(b)(2 and related justifications
• Draft controlled correspondence for deficiency letters
• Characterize formulations using particle size, aerodynamic performance (NGI/ACI), spray geometry, viscosity, osmolality
• Support bioequivalence strategy development (IVIVC, biowaiver, sameness)
• Analyze data with JMP, Minitab, Python, or Excel to derive actionable conclusions
• Collaborate with device/engineering teams on product-device compatibility and human factors
• Drive tech transfer and scale-up with CDMOs
• Author/review protocols, batch records, and GMP/GLP CMC documentation; manufacture developmental/clinical batches

• Bachelor's Degree with 4+ years in OINDP formulation development or drug-device formulation, or
• Master's Degree with 2+ years in OINDP formulation development, or
• PhD with 1+ year in OINDP formulation development
• Working knowledge of ICH guidelines and FDA/EMA expectations for OINDP
• Experience with cGMP/compliance (desirable)
• Experience with excipient selection and justification
• Ability to work across formulation, analytical, clinical, QA, operations, IP, and regulatory functions

• cross-functional collaboration
• strong analytical thinking
• clear scientific communication
• OINDP formulation development
• pharmaceutical dosage form development
• gMP/gLPl familiarity