Microbiology Manager At Minapharm Pharmaceuticals
Job description
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 description summary:
Minapharm Pharmaceuticals is heavily expanding its projects throughout its global operations. The job position described below is responsible to supervise and manage the Quality Control Microbiology Department, direct day to day operations and assuring that Microbiology Lab operations and testing are performed in compliance with applicable regulations, company specifications, procedures, policies and current industry practices.
Duties and responsibilities:
The duties of the Microbiology Manager will specifically include (but are not limited to) the following:
Maintain proficiency in all Microbiology laboratory methods, processes, and procedures.
Manage activities inside microbiology Lab according to work load.
Ensure compliance with SOPs, Quality requirements, Environmental, Health and Safety programs.
Maintains awareness of cGMP, applicable regulatory required as ISO 9001, 14001, 45001, 14644& 17025.
Monitor sampling and testing as required for environmental and personnel monitoring, samples of raw materials, in-process product, and finished product.
Monitor sampling and testing as required of critical systems (Purified Water, Clean Steam, Clean Compressed Air, etc...).
Train and qualifies personnel for Aseptic Operations, Media fill, and associated documentation.
Train new Microbiologists, assigns tasks, monitors their performance, and reviews their testing and documentation.
Monitor calibration and performance checks of instrumentation and devices such as RCS, pH meters, balances, Incubators and refrigerators, issue report of deviation in case.
Participate in creating new product as test method validation, preparation of MOH registration file.
Approve/Authorize additional testing/re-testing/re-sampling as appropriate, based on review of test results, and Lab investigation.
Participate/co-ordinate in Internal Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities.
Qualifications and skills:
From 12-15 years of experience in the pharmaceutical manufacturing field in Microbiology with minimum of 7 years at the managerial level.
Advanced degree (Master’s Degree, M.B.A, and/or Ph.D.) in scientific or business-related discipline.
Data analytical skills developed through academia and work experience
Critical thinking and strategic business plan generation
Excellent English language skills
Up to date with the most recent scientific literature.
Outstanding interpersonal and organizational skills, leadership abilities, and oral and written communication
Be able to diagnose problems quickly and have foresight into potential issues