Sr. Process Engineer, Third Party Management

Job Title: Sr. Process Engineer, Third Party Management

Location: Columbus, OH

Job Type: Full time

Req : 12238

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. Process Engineer, Third Party Management to join our team.

In this role, you will be responsible for leading the transfer of 3rd party/ CMO products (externally contracted for development/ manufacturing/ testing, Buy-ins, Site Transfers (in/ out), life-cycle) from R&D to Commercial Operations as a Process Champion from Hikma:

• Support technical evaluation of 3rd party/ CMO capabilities, process development, registration lots manufacturing, and FDA filings.
• Perform evaluation, scale-up, process validation, site transfer (in/out), and lifecycle maintenance.
• Coordinate quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects.
• Lead the transfer of selected in-house products (on-site development/ manufacturing/ testing) for cross learning and alignment with Hikma’s internal practices.

• Consult as Process Champion on cGMP/ FDA/ Hikma quality requirements and lead the planning and execution of process scale-up/ validation and commercial production for 3rd Party/ CMO products during project selection, process development, filing, transfer, evaluation, launch and life-cycle phase.
• Lead as Hikma’s Technical Services representative during 3rd Party/ CMO site visits, and project selection, and execution.
• Consult on Hikma’s commercial operations requirements for process/ equipment, analytical/ physical testing, validation, documentation, training, cGMP and QbD controls etc.
• Drive gap assessment for process scale-up, and process design/ improvement initiatives (e.g. PAT, DOE) during development/ registration/ transfer and lead mitigation and implementation activities.
• Lead strategy development (e.g. lot sizes, number of lots, etc.) and drive requirements (e.g. protocols, batch records, etc.) for scale-up, evaluation, transfer, and validation batch production.
• Execute project deliverables by employing prior knowledge/ experience and/ or by continuously learning of unique dosage forms and process technologies (e.g. soft gels, transdermal patches, etc.).
• Co-lead process development, registration, and FDA filing tasks with R&D and project teams from 3rdparty/ CMO and Hikma and establish robust control strategy for future commercial process.
• Collaborate with development partners (e.g. Product Development) during development, pilot lot production, registration, etc. to develop product formulation, and process flow, and resolve complex issues relating to CPPs, CQAs, AQL, analytical methods/ testing, quality deviations and other process risks.
• Collaborate with Analytical Development, Quality labs etc. to set-up testing requirements for in-process controls, release and stability; influence in establishing product specifications based on process and data trends.
• Lead planning and execution of complex experimental/ developmental studies to mitigate future process risks by evaluating financial and quality impact for Hikma.
• Create and/ or review documentation (e.g. SAP Master Data, development/ registration protocols, reports, batch records etc.) based on process design parameters (e.g. formulation and processing steps) mutually agreed upon with product development partners and quality procedures.
• Travel to 3rd Party/ CMO locations during development/ registration manufacturing to co-lead with development partners, implement process design, and mitigate risk-factors for scale-up/ process validation.
• Drive effective Risk Assessment processes at applicable development gates, in collaboration with development partners; identify critical risk areas and develop remediation plans to address them.
• Co-lead with Product Development to generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation.
• Consult on FDA filing/ correspondence strategy and documentation requirements for…