Sr. R&D Specialist – Process Development at Hikma Pharmaceuticals – Amman

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Job Description

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.

Skills

 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 Details

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
Unspecified

Number of Vacancies
1

Preferred Candidate

Career Level
Mid Career

Years of Experience
Min: 7 Max: 10

Nationality
Jordan

Degree
Master’s degree

Education

Pharmacy or Pharmaceutical Technology

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