Sr. Scientist, Formulation Development

Job Title:      Sr. Scientist, Formulation Development        

Location:      Columbus, OH

Job Type:     Full time

Req ID:         11881

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Sr. Scientist, Formulation Development to join our team.  

Hikma is expanding its orally inhaled and nasal drug product (OINDP) capability, and we're looking for a formulation scientist who wants to work on technically demanding, high-impact programs from early development through to regulatory submission and launch. This role sits within our growing OINDP formulation team and will be pitched at level depending on your experience. What matters most is depth of knowledge, scientific rigor, and the ability to work at pace across a commercially oriented pipeline.

Key Responsibilities: 

• Design and execute formulation development studies for OINDPs, applying QbD principles throughout
• Lead or contribute to CMC sections of regulatory dossiers (ANDA, NDA, 505(b)(2) — formulation development reports, excipient justifications, comparability studies. Draft controlled correspondence and responses to project specific deficiency letters as needed.
• Characterize formulations using methods relevant to OINDP: particle size, aerodynamic performance (NGI/ACI), spray geometry, viscosity, osmolality, and related physical chemistry
• Support Bioequivalence strategy development, including, IVIVC, biowaiver arguments, and Q1/Q2/Q3 sameness justifications
• Analyze and interpret experimental data using relevant tools (e.g. JMP, Minitab, Python, or Excel) to draw clear scientific conclusions, identify trends, and define the next cycle of formulation or process development with confidence
• Collaborate with device/engineering teams on product–device compatibility and human factors considerations
• Drive tech transfer and scale-up activities, including work with CDMOs
• Author and review protocols, batch records, and CMC documentation to GMP/GLP standards. Manufacture developmental and clinical (pilot / registration) batches.

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Bachelor’s Degree (Pharmaceutical Sciences, Chemistry, Chemical Engineering) plus a minimum 4 yrs experience with the following:  
  • Hands-on OINDP formulation development experience or drug-device formulation is particularly valued. Experience in formulation development of pharmaceutical dosage forms is valued. OR 
• Master’s degree (Pharmaceutical Sciences, Chemistry, Chemical Engineering) plus a minimum 2 years of experience with the following: 
  • Hands-on OINDP formulation development experience or drug-device formulation is particularly valued. Experience in formulation development of pharmaceutical dosage forms is valued. OR 
• PhD (Pharmaceutical Sciences, Chemistry, Chemical Engineering) plus minimum 1 years of experience with the following:
  • Hands-on OINDP formulation development experience or drug-device formulation is particularly valued. Experience in formulation development of pharmaceutical dosage forms is valued.
• Working knowledge of ICH guidelines and FDA/EMA expectations for OINDP
• Experience in working to cGMP and compliance requirements is desirable but not essential.
• Experience with excipient selection and justification (preservative systems, antioxidants, tonicity agents).
• Ability to work effectively across formulation, analytical, clinical, QA, operations, IP, and regulatory functions.

Preferred Qualifications:

• Experience with scale up in GMP environment
• Experience with regulatory submissions (ANDA / NDA)
• Knowledge (understanding and interpretation) of analytical characterization techniques
• Experience with good documentation practices for GMP batches
• Experience with use of statistical tools in data analysis
• Knowledge of in-vitro in-vivo correlation 

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.