Title: Senior Scientist (Aurora,IL)

Job Summary

THIS POSITION IS LOCATED IN OUR AURORA, IL FACILITY

Summary:

The Sr. Scientist – Pharmaceutical Technology, with guidance, will perform various duties related to process development/optimization, Tech Transfer, process validation activities as mandated by cGMP’s policies/procedures and Frontida quality standards. Perform data analysis of production processes, new products/process technology transfers, and validation. Prepare and execute process development/optimization study protocols, manufacturing and packaging experimental/ feasibility study/ validation batch records and protocols and complete interim and/or final summary reports for marketed and new products. Perform or assist on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing/packaging process, equipment troubleshooting, SOP preparation and review. Work closely with internal and client company Research & Development, Quality Control, Operations, Quality Assurance, Engineering, Materials Management, and PM groups. Represent Process Development (PD) at assigned project team meetings.

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Responsibilities

  • Prepare and execute protocols, batch manufacturing records, and interim/final reports for experimental/feasibility/stability/optimization/validation batches
  • Make sure that the sampling & testing are completed, while executing the above studies, and are in line with the protocol/plan
  • Monitor all in-process data/analytical data and escalate to management as needed
  • Author/update master batch records, as required
  • Perform or assist technical transfers, scale-up or Scale down evaluations, troubleshooting of manufacturing/packaging process and equipment
  • Review, as necessary, all pertinent Project Quotes, NDA / ANDA documentation, batch history, and technical transfer reports prior to validation activities
  • Prepare and execute Validation documents (protocols, batch records, and reports)
  • support Operations as needed for initial commercial batch manufacturing so that Operations team learns full product knowledge
  • Coordinate with Facilities Engineering, Operations/Mfg./Pkg., R&D, QC, and QA for timely execution of manufacturing and packaging experimental/ feasibility study/validation projects
  • Develop & manage cross-functional interdepartmental project plans, identify resource conflicts, facilitate communication across the departments that impact the timeline
  • Discuss any unusual observations during manufacturing, conduct and/or support investigations on deviations as needed
  • Follow established practices and procedures in analyzing situations or data from which answers can be readily obtained
  • Conduct training to related department personnel on all technical and project- related documents, such as Batch records, Deviations, Investigations, protocols, and SOP etc.
  • Interact daily with internal/external team members and/or functional peer groups, other teams/departments
  • Present technical information, as needed

Qualifications

  • Bachelors of Science degree in Pharmaceutical Technology or Chemical Engineering
  • 10+ years’ with BS or 8+ years’ with MS or 6+ years’ with PhD of relevant experience in the above field

 

Knowledge and Skills

  • Working knowledgeable of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA, other regulatory requirements, lean manufacturing, and Six-Sigma concepts, continuous improvement etc.
  • Well versed with pharmaceutical unit operations and their scale-up principles
  • Working knowledge of pharmaceutical manufacturing principles, process techniques, hands on equipment knowledge, rand regulatory practices
  • Modified Release Dosage formulation & process development – mainly oral solids
  • Particle/Pellet coating (FBD Wurster)
  • Good Understanding of QbD (CPPs/CMAs/CQAs), risk assessment, and PATs
  • Well versed with Analytical test methodologies (ex: BU, CU, Assay, and Dissolution profile, Discriminating media, etc.)
  • Understanding of equipment qualification/calibration requirements, cleaning validation, verification, and Process validation
  • Basic/Intermediate statistical analysis {variance, SD, Cp, Cpk, regression analysis, etc.)
  • Understands the fundamental CMO/CRO business drivers of Frontida
  • Personal computer operation and MS applications (Word, Excel, PowerPoint, MS Project etc.)

 

 

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