Research Specialist - Biopharmaceuticals

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

We're hiring several positions in the Research Technology department.

-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).

Upstream:

• Participation in maintenance, development and upgrade of laboratory facilities.
• Designing, performance and execution of upstream experiments related to the development and optimization of pipeline products and/or improvement of cultivation strategies for marketed products including all necessary documentational aspects.
• Designing, performance and execution of upstream experiments on behalf of other departments yeast fermentation, protein purification, including documentation if applicable.
• Perform continuous optimization of process descriptions and their depiction in standard operation procedures (SOP’s).
• On-time planning of upstream programs for all relevant products/cell lines and supervision of their implementation according to cGLP/cGMP/ICH guidelines.
• Issuing relevant standard operation procedures (SOP’s).
• Analysis and evaluation of results including troubleshooting.
• Documentation and filing of results.
• Project related literature screening.
• Writing of regular reports.
• Correspondence with international partner companies related to assigned projects.
• 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).

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.