Seeking a highly motivated and scientifically rigorous individual to join the Product Development (PD) team as a ‘Senior R&D Specialist -Process Development’. This role includes but is not limited to leading process development activities to support project team goals and will be responsible for: The successful scale-up and optimization of manufacturing processes from lab through production scale and the technical aspects related to troubleshooting of new products:
- Supervision/support of validation and launch activities. Technology transfer between sites Pre/post submission product support.
- Partners closely with development teams to ensure successful transfer of process knowledge during technical transfers.
- Supervises scale-up and process validation activities by ensuring smooth and on time technology transfer (TT) and launch activities.
- Effectively identifies critical process parameters (CPPs) with appropriate ranges to ensure robust and capable manufacturing processes.
- Resolves technical problems while meeting quality and schedule objectives.
- Provides timely investigations, protocols, data analyses, and conclusions by writing and reviewing scientifically valid technical evaluations and ensuring project initiatives will achieve successful outcomes.
- Assesses product impact. Prepares regulatory submission documents.
- Supports internal/external audits or inspections.
A strong pharmaceutical and technical background about problem solving and process/product improvements in support of manufacturing operations.
- Knowledge and awareness on regulatory and submission/filing approaches Thorough understanding of the change control (CC) procedures in the pharmaceutical industry and any impact on product quality.
- A strong background in pharmacokinetics and bioequivalence sciences.
- Understanding of cGMPs, SOP, and up to date knowledge on regulatory guidance’s and systems for drug products.
- The ability to manage and meaningfully advance multiple tasks and projects with a high degree of initiative and self-motivation.
- Well understanding and knowledge of process development/support in a cGMP environment and awareness of regulatory expectations.
- Experience solving ambiguous problems, compile and statistically analyze data, draw appropriate conclusions, and make presentations to cross-functional audiences.
- Detailed understanding of all stages of process validation in pharmaceuticals.
- Knowledge of analytical techniques for characterization of drug products.
- A hard-working, passionate about science, team player that can effectively collaborate in a dynamic, cross-functional matrix environment.
- Job Location
- Amman, Jordan
- Company Industry
- Pharmaceutical Manufacturing
- Company Type
- Employer (Private Sector)
- Job Role
- Research and Development
- Employment Type
- Full Time Employee
- Monthly Salary Range
- Number of Vacancies
- Career Level
- Mid Career
- Years of Experience
- Min: 7 Max: 10
- Master’s degree
Pharmacy or Pharmaceutical Technology