Vacancy: Biologics Consultant

Date 22 Oct 2021
Location Accra
Job Type Contractor/Consultant
Industry Public Health
Description


Company Profile


The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.



USP is an independent organization with nearly 200 years of experience developing quality standards for medicines. Through its global public health programs, USP strengthens medicines quality assurance systems, increases the supply of quality-assured medicines, and develops capacity to detect and remove poor-quality medicines from the market. By sharing scientific expertise and providing technical support and leadership, USP helps local regulators improve and sustain local health systems and enables manufacturers to supply quality-assured essential medicines for years to come. Through these efforts, USP is able to help detect and identify poor quality health products in disease areas such as HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as helping safeguard the maternal, newborn, and child health sectors.




Job Description


Purpose

USP Ghana is involved with capacity building of personnel in the Regulatory Systems Strengthening sector and particularly in the area of Evaluation of biological dossiers. Thus, USP-Ghana needs a consultant who will be responsible for performing geared towards capacity building in Biologics evaluation.



Scope of Work

The consultant will be charged with the development and implementation of the following:




  • Development of materials required for capacity building in Evaluation of biological dossiers. Materials must include topics such as:

  • Manufacturing, GMP, validation, stability, and specifications for biologics.

  • Biologic product manufactured in prokaryotic cell and mammalian cell lines.

  • Evaluation of a monoclonal antibody (Mabs).

  • Manufacturing, GMP, validation, stability, and specifications for vaccines.

  • Delivery of training in Evaluation of Biologic dossiers.

  • Update of existing materials used for capacity-building activities.



Deliverables

The consultant will provide the following upon resumption of the above role:




  • Training materials

  • Training reports

  • Future areas for training or further capacity building




Required Skills or Experience


Successful consultant should have enough experience in Regulatory Systems Strengthening activities (experience working with Medicines Regulatory Authorities is an advantage) i.e. 5-10 years and of a Scientific background eg, Pharmacist, Biochemist, Chemical Analyst, etc.





How To Apply


Applicants should send their CVs and daily rate by email.




Note



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