Research Specialist At Minapharm Pharmaceuticals
Research Specialist - Biopharmaceuticals at Minapharm Pharmaceuticals
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
-Protein Purification:
Designing, performance and execution of purification experiments related to the development of new purification strategies for pipeline products including all necessary documentation aspects.
Designing, performance and execution of purification experiments on behalf of other departments like upstream, protein analytics and stability, including documentation if applicable.
Perform continuous optimization of process descriptions and their depiction in standard operation procedures (SOP’s).
On-time planning of purification programs for the assigned projects and their implementation according to cGLP/cGMP/ICH guidelines.
Participation in preparation of official technical documents for other departments of the organization or related affiliates or external parties (eg.CTD/product dossiers for the EDA, technology transfer documents for production of external CMOs).
-Protein Stability & Drug Development:
Performance and execution of experiments in the respective unit which are related to the improvement, implementation and validation of analytical methods for stability testing of products including all necessary documentational aspects.
Performance and execution of protein stability studies in the respective unit on behalf of other departments like upstream, protein purification, protein characterization, including documentation if applicable.
Participate in design of final sterile filtration step and subsequent filling procedures.
Participate in screening of primary packaging material for each development project and establishing container closure integrity including extractables & leachables studies.
Participate in overall drug product development including pre-formulation studies, selection of excipients/formulation buffer studies and lyophilization development. This applies to all potential dosage forms (prefilled syringes/vials, lyophilized powder,..).
-Protein Characterization:
Performance and execution of experiments that are related to the development of new analytical methods for pipeline products and/or improvement of analytical methods for marketed products including all necessary documentation aspects.
Continuous optimization of process descriptions and their depiction in standard operation procedures (SOP’s).
On-time planning of analytical methods implementation and validation according to ICH guidelines.
Supporting and cooperation with Stability Testing Unit in terms of method development/improvement and troubleshooting if applicable.
Participation in preparation of official technical documents for other departments of the organization or related affiliates or external parties (eg.CTD/product dossiers for the MOH, technology transfer documents for production of external CMOs).
Qualifications:
· Bachelor’s or Master’s degree in Pharmaceutical Sciences .
· Strong computer, scientific, and organizational skills.
· Excellent communication in English (oral and written).
· Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Job Location: 10th of Ramadan.