Vacancies At Minapharm Pharmaceuticals
1-QC Analyst
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
About The Job
To maintain quality standards by analyzing incoming Raw materials, in-process, finished products and stability samples in chemical lab. Record quality results according to relevant specifications, SOPs. Fulfill GLP & GMP guidelines.
Responsibilities
-Maintain quality standards by analyzing incoming materials (Raw and Packaging materials), in-process and finished products & stability samples according to relevant specifications, test methods and Standard Operating Procedures.
-Record quality results into quality database, complete logs and report results.
-Calibrate, operate different instruments used in analysis according to relevant SOPs and communicate with agents for maintenance in case of need.
-Follow GMP, GLP rules according to relevant SOPs.
Requirements:
Education: Pharmacy Graduate is a must.
Experience: 3 years experience.
Location:10th of Ramadan
Apply Here
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2-Research Specialist – Protein Characterization
About the job
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
Main job duties/tasks:
-Participation in maintenance, development and upgrade of laboratory facilities
-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
-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 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.
Apply Here
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3-Validation Specialist / Sr.Specialist – Qualification & CSV
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
Summary:
Perform all validation activities related to premises, equipment & utilities qualification, calibration and computerized system validation. Oversight site compliance with data integrity.
Responsibilities
Technically Write Validation and qualification Documents (Risk Assessment, Qualification Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs
Perform & follow up overall qualification/validation activities include (HVAC, UDAF, Incubators, Equipment qualification, Compressed air Qualification, Steam Qualification and water station Qualification etc….).
Technically write calibration Plans and follow up the implementation.
Provide inputs to and administration of the site master validation program as well as assist in maintaining the site validation master plan.
Develop validation policy with roles and responsibilities.
Review/assess proposed changes to qualified equipment via CAPA, change control and work orders to identify requirements necessary to maintain validated status.
Perform computer system validation across the facility related functions including (laboratory equipment and system, engineering utilities, production machines)
Develop and execute validation protocols for equipment and systems in the pharmaceutical industry.
Oversee risk assessments related to validation and qualification activities.
Collaborate and organize with cross-functional teams to implement validation strategies.
Follow up implementation of maintenance procedures, calibration procedures, and other instrument support documents.
Participate in cross-functional teams.
Perform other relevant tasks as requested.
Qualifications
·From 2 to 6 years of relevant experience.
·BSc in pharmaceutical sciences, engineering, computer science or other related disciplines.
·Basic knowledge of EDA, WHO, ICH, PIC/S & EU guidelines and/or regulations related to premises, equipment & utilities qualification, calibration and computerized system validation.
Location:10th of Ramadan