وظائف شاغرة لدى شركة ادوية الحكمة

Job Description

SUMMARY:

R&D Manager:

• Responsible for leading and overall coordination of complex drug development projects.
• Job entails developing robust products and processes that are scalable, stable and bioequivalent to the Reference Product.
• Reports on project status, communicates any issues, problems or additional information to project team and management along with recommendations of solutions.
• The candidate should be acquainted with current practices and trends within industry to meet compliance and keep up with technology.
• Attention to detail and excellent communication skills are necessary.
• Candidate should develop and motivate staff to their full potential.
• The individual in this position must be versatile, able to accommodate the needs of different developmental projects.
• Requires understanding of Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs).

FUNCTIONS:

• Responsible for development of various complex pharmaceutical dosage forms (e.g. oral and topical) literature search, pre-formulation, formulation design, and development of stable, bioequivalent and manufacturable generic pharmaceutical formulations.
• The incumbent is responsible for working with cross-functional departments such as AR&D Production, Quality, Regulatory Affairs, and Portfolio Management. Manager provides required documentation to RA in a timely manner to support regulatory filings and supplement filings as needed.

RESPONSIBILITIES:

• Candidate must be a good mentor and motivator.
• Develop robust and scaleable formulations and processes for different pharmaceutical dosage forms.
• Evaluate patents and develop non-infringement strategies. Capable of developing Paragraph IV products.
• Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timelines.
• Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).
• Author and review technical documents including Product Development Report (PDR) and other relevant documents for regulatory filing purpose.
• Prioritize and manage multiple projects with overlapping deadlines.
• Coordinate with Regulatory Affairs for product filing and addressing deficiencies.
• Review of batch records, process characterization reports, validation reports and investigation reports.
• Develop and manage project budgets, and timelines, and project status reports.

Skills

MINIMUM QUALIFICATIONS:

Candidate must have a MS with a minimum of 15 years or a Ph.D. degree in Pharmacy with a minimum of 10 years of relevant experience in product development in generic pharmaceutical industry.

Generic R&D experience and a successful track record of submissions is a must.

Education

Pharmacy