Senior Process Engineer - Pharma Scale-Up Leader

Jobtailor; Columbus (OH); On-site; USD 110,000 - 180,000; Full time

Job summary

Hikma in the United States seeks a seasoned Process Transfer and Validation Leader to drive cGMP compliance, registration filings (ANDA/NDA/PAS), and scale-up for both 3rd party/CMO and in-house products. The role requires leading cross-functional teams across R&D, Regulatory, Quality, and Production to ensure robust processes and successful product launches.

You will conduct risk assessments, develop robust control strategies, and guide documentation for filings and validation batches.

Qualifications

• > Bachelor's degree holders with 6+ years pharma experience or a Master with 4+ years; or 7+ years in related field; or PhD with 2+ years.
• + Experience in technology transfer, process development/validation, formulation, manufacturing, or quality within pharmaceuticals.
• + Strong knowledge of FDA, cGMP, and regulatory requirements (DEA, OSHA, etc.).
• + Expertise in formulation development, process scale-up, validation/PPQ, and equipment.
• + Ability to travel domestically and internationally as needed.

Responsibilities

• Consult as Process and Formulation Champion on cGMP/FDA quality requirements and execute process registration (ANDA, NDA, PAS) and scale-up/validation for 3rd party/CMO and in-house products.
• Lead Hikma’s Technical Services representative activities for in-house processes and site visits.
• Drive risk assessments and data analysis for process scale-up and design improvements (PAT, DOE).
• Lead strategy development for filing and validation, including lot sizes, sampling plans, and documentation for registration/transfer.
• Collaborate with Regulatory Affairs to author/review FDA filing documentation (ANDAs, NDAs, PAS).
• Coordinate with Quality/Change Management and DRA to implement critical process changes and CAPA.

Skills

Cross-functional leadership

DOE

Process scale-up

CAPA implementation

Data analysis

Regulatory knowledge

Education

Bachelor's degree in Engineering/ Chemistry/ Pharmacy

Master's degree in a related field

Ph.D. in a related field

Job description

Hikma in the United States seeks a seasoned Process Transfer and Validation Leader to drive cGMP compliance, registration filings (ANDA/NDA/PAS), and scale-up for both 3rd party/CMO and in-house products. The role requires leading cross-functional teams across R&D, Regulatory, Quality, and Production to ensure robust processes and successful product launches.

You will conduct risk assessments, develop robust control strategies, and guide documentation for filings and validation batches.