Summary
The Center for Breakthrough Medicines is seeking a Microbiological Quality & Sterility Assurance (MQSA) Senior Specialist to join the Quality & Compliance team. This position will be involved in programs to ensure microbiological quality and sterility assurance of sterile product at the Center for Breakthrough Medicines, while adhering to applicable regulatory requirements and industry best practices.
The Senior Specialist will ensure compliance of aseptic manufacturing, environmental monitoring, and microbiological contamination control measures. The position will collaborate with Microbiology and Manufacturing partners to support ongoing aseptic training program to including gowning, aseptic technique and cleanroom behavior. The Senior Specialist will be responsible for routine administration of the site aseptic process simulation (APS) program, in addition to supporting the site contamination control strategy (CCS).
It will be the responsibility of the Senior Specialist to build impactful relationships and collaborate across the Center for Breakthrough Medicines organization to deliver exceptional service and the highest quality product to our clients in a highly regulated environment.
If you have experience executing Sterility Assurance program elements, we encourage you to consider building your future with The Center for Breakthrough Medicines.
Responsibilities
- Supports development and lifecycle management of the contamination control governance elements, including sterilization validation, environmental monitoring, cleaning & disinfection, and utilities qualification (e.g. WFI system, compressed gases)
- Helps in the development and implementation of the site Sterility Assurance Program
- Participates in the administration of end-to-end (E2E) microbiological control strategy for production processes from incoming raw materials through final product release
- Collaborates with Manufacturing to meet US and EU aseptic processing requirements
- Adheres to industry regulations and guidance documents when assisting in the creation and implementation of standards, policies, and site procedures (e.g., ISO 14644, Sterile Drug Products produced by Aseptic Processing-GMP, EU Annex1, and EU Guideline-GMP Specific to Advanced Therapy Medicinal Products)
- Supports compliance of site manufacturing programs, processes, and facility systems
- Performs gap assessments and collaborates in the implementation of action plans to correct identified deficiencies to improve quality processes
- Provides sterility assurance expertise as author, reviewer and/or approver for cGMP documents including, but not limited to, SOPs, work instructions, and batch records
- Authors/supports APS/media fill protocols and summary reports to ensure robust and compliant documentation of processes and validation studies
- Participates in the development of cGMP and other GxP training as needed
- Provides microbiological expertise to support non-conformances, deviations, CAPAs and complaints related to sterility assurance
- Supports preparation for regulatory and client audits
- Supports sterility/microbial specification development for incoming raw materials and components.
- Collaborates with internal and external business partners, including other CBM business units or departments and external suppliers, in support of continuous improvement initiatives
Qualifications
- Collaborative nature and ability to work well in teams
- Capable of data analysis, including ability to collect and analyze data to identify trends and detect problems and key issues
- Demonstrates good judgement; able to problem solve and to define decision criteria to recommend the most appropriate course of action
- Ability to plan and organization to meet goals and objectives within defined timelines
- Possesses strong communication skills – oral and written
Education & Experience
- Bachelor’s Degree in Microbiology, Biology, Chemical Engineering, Biomedical Engineering or closely related discipline
- 5+ years of experience in pharma/biotech industry; minimum 3 years of aseptic processing experience in a GMP environment
- Demonstrated experience in Aseptic Process Simulation (APS) execution
- Cell and Gene Therapy experience a plus
- Knowledge of analytical methods relevant for microbial control
- Experience in microbiology, sterilization validation, terminal sterilization, aseptic processing and environmental controls for a pharmaceutical, medical device or related manufacturing environment
- Proven track record troubleshooting process non-conformances and out-of-specification test results
- Proficient in providing sound and compliant resolutions to issues utilizing robust CAPA processes
