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Associate Scientist, Formulation Development
Hikma PharmaceuticalsAssociate Scientist supporting formulation development at Hikma Pharmaceuticals. Involves technical support, regulatory filing, and collaboration across manufacturing sites.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmaceutical formulation development and technology transfer, with a strong focus on regulatory compliance and technical documentation. Proficient in managing cross-functional collaboration and ensuring successful execution of manufacturing processes.
Highest-signal resume keywords
Pharmaceutical Formulation DevelopmentTechnology TransferTechnical WritingRegulatory ComplianceFDA Current Good Manufacturing Practices
ATS Keywords
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Hard Skills
Pharmaceutical Products Technology TransferTechnical DocumentationManufacturing Process OptimizationBatch Record ReviewLab Trials Execution
Soft Skills
Independent WorkTask ManagementCollaboration
Tools & Technologies
MS OfficeSAP
Certifications & Qualifications
BSc PharmacyMSc in Pharmaceutical Sciences
Industry Keywords
Regulatory FilingQuality StandardsTechnical OversightCross-Functional TeamsCommercial Production
About the role
Key responsibilities & impact- Perform effective transfer of manufacturing know-how and product knowledge across Hikma manufacturing sites
- Provide technical support for product troubleshooting and process optimization
- Support regulatory filing activities by generating and supplying the required technical documentation that is monitored by R&D
- Lead and support the successful transfer of manufacturing processes, technical knowledge, and product know-how for pharmaceutical products
- Act as the R&D representative during validation batches manufacturing of new product launches, providing on-site technical oversight and support as needed
- Conduct comprehensive reviews of manufacturing and packaging batch records to ensure compliance with approved processes, quality standards, and regulatory requirements
- Facilitate the effective transfer of technical knowledge from Product Development to Manufacturing by proactively identifying, assessing, and resolving technical risks and gaps
- Collaborate closely with cross-functional teams, including Production, Quality, Supply Chain, Regulatory Affairs, Project Management Office and Technical Support Unit to ensure successful execution and alignment during the manufacture of the first three commercial/validation batches and support a smooth transition to routine commercial production
- Review and evaluate technical documentation and outsourced products transfer dossiers for pharmaceutical products planned for transfer from Hikma Jordan (HJ)/Outsourcing lab or Licensors to other Hikma manufacturing sites
- Assess the completeness, technical feasibility, regulatory compliance, and manufacturing readiness of transfer packages, and provide scientifically sound recommendations to support successful technology transfer activities
- Prepare and review the supportive and technical documents that are intended to be transferred to other Hikma manufacturing sites or provided to Regulatory Affairs or authorities to complete the registration process at the intended markets
- Ensure all deliverables are completed within the predefined timelines, supported by thorough documentation and, when necessary, targeted research to enable efficient replies and compliant submissions
- Execute lab trials and submission batches independently in compliance with Quality standards
Requirements
What you’ll need- 1-4 years of experience in pharmaceutical formulation development of different dosage forms or pharmaceutical products technology transfer
- BSc Pharmacy (MSc in Pharmaceutical Sciences or Pharmaceutical Industry is preferable)
- Excellent command of the English language (written and verbal)
- Excellent technical writing and documentation skills
- Proficiency in MS Office (Word, Excel, PowerPoint)
- Familiarity with SAP (preferred)
- Ability to work independently and manage multiple tasks
- Knowledge of FDA Current Good Manufacturing Practices (cGMP)
Benefits
Comp & perks- Health insurance
- Flexible working hours
- Professional development opportunities