Protein Stability and Drug Product Development Unit Head

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:

Assist department head in organizing and structuring protein stability and drug product development activities in R&D, and all related tasks ensuring successfully developed formulation and stable drug product in the final formula and primary package, to achieve the company’s goals.

-Duties:

• Assist in organizing the activities of the subordinates in the respective unit:

a. Design of experiments for assigned projects.

b. Equipment acquisition.

c. Routine stability studies.

• Assist in coordination of overall drug product development,, selection of excipients, formulation buffer studies on internal level in R&D, and external level with other departments or other external third parties (eg. CMOs, international partner companies,..). This applies to all potential dosage forms (prefilled syringes/vials, lyophilized powder,..).
• Assist in coordination of screening of primary packaging material for each development project
• Assist in lead support of Minapharm sterile area and/or external CMOs in product specific sterile filtration and filling in set-up
• Assist in the supervision of maintenance, development and upgrade of laboratory facilities for the respective unit.
• Participation in maintenance, development and upgrade of laboratory facilities.
• Designing, 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.
• Designing, 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,..).
• Involvement in performance and execution of experiments in the other units of stability department, on behalf of other departments like upstream, protein purification, protein characterization, including documentation if applicable.
• Continuous optimization of process stability program descriptions and their depiction in standard operation procedures (SOP’s).
• On-time planning of stability programs according to ICH guidelines.
• Supporting and cooperation with Protein Characterization department in terms of method development/improvement and troubleshooting if applicable.
• 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:

• Experience:

From 6-9 years of Research / Quality Control Experience in Stability& Formulation Development.

• Education:

Bachelor degree of Pharmacy.

• Training:

Hands on experience needed relevant to Protein Characterization methodologies in addition to drug product formulation strategies, especially parenteral products.

• Knowledge:

Solid knowledge of Protein Characterization methodologies, in addition to drug product formulation strategies, especially parenteral products.

Job Location : 10th of Ramadan.