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R&D Specialist - Process Development

Amman, Jordan

Expires in a month


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.

Education

Pharmacy or Pharmaceutical Technology


Job Details

Job Location

Amman, Jordan

Job Role

Research and Development

Employment Status

Full time

Employment Type

Employee

Number of Vacancies

1

Preferred Candidate

Career Level

Mid Career

Years of Experience

Min: 7 Max: 10

Degree

Master's degree


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Pharmacovigilance Officer

Amman, Jordan

Expires in 14 days

Job Description

Assist in the preparation/revision of company core data sheets (CCDSs) and reference safety information (RSI) for MENA products.

Assist in the preparation/review of product information and safety variations in MENA.

Assist in literature screening and signal detection for MENA products.

Assist in the preparation of health risk assessment reports in MENA.

Assist in the preparation of risk management plans and implementation of risk minimization measures in MENA.

Assist in safety planning and review of Hikma-sponsored clinical studies and patient support programs in MENA.

Assist in the preparation and submission of periodic safety update reports in MENA.

Assist in the preparation/review of safety data exchange agreements for MENA products.

Skills

Medicine or Pharm D or MPharm

Education

Medicine or pharmacy or pharm.D


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