About Minapharm:
Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline. Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region. Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, has incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.
Our Values:
· Diversity & Respect
· Integrity & Accountability
· Collaboration
· Leadership & Empowerment
· Innovation & Continuous Learning
Job Summary:
Duties:
Creating and executing method development and method validation test protocols for finished products and generating the appropriate analytical methods.
Creating and following up maintenance plan for all instruments in R&D analysis lab.
Securing & following up availability of all analytical resources (Columns, reference standards, reagents, solvents …..etc).
Sampling and testing of raw materials, intermediates and finished products using current pharmacopoeias, any associated ‘wet’ chemistry and instrumental techniques (HPLC, IR, UV), as appropriate.
Preparing R&D reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports.
Stability testing of products for new formulations and ongoing stability trials, using physical (pH, viscosity) and instrumental (HPLC, UV) techniques, as appropriate.
Writing/reviewing Standard Operating Procedures (SOPs).
Supervise, develop and train R&D analysts.
Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion.
Observing and complying with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
Observing and complying with company Health and Safety Policies.
Observing and complying with company Standard Operating Procedures (SOPs).
Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
Job Requirements:
.Analytical method validation.
.Development of analytical methods.
Highly proficient in the use of key analytical equipment (HPLC, GC, IR, UV) and the testing of finished products.
