Job Summary
Role Summary
As the Senior Microbiologist, you will provide the essential support to the Microbiology team that allows the release of manufactured product to the critically ill patient. Your role will include equipment and method validations, continuous process developments, and supervising the team with day-to-day activities ensuring GMP and regulatory compliance are definitively maintained. You will be supporting the team, as required, in all areas of the department, including but not limited to, Sterility testing, Bioburden testing, Endotoxin testing, Mycoplasma testing, microbial enumeration, microscopy & identification, and defining LEAN processes that allows the team to operate at optimal efficiency.
In this role, you will be key participant in the delivery of Microbiological analysis and will develop your practical knowledge into a multi-subject matter expert. Please note that this is a shift-based role (Sunday - Wednesday OR Wednesday -Saturday, 08AM 1745PM )based onsite at our site in Stevenage.
Key Responsibilities
Responsible for supporting the critical operations by ensuring the laboratory and general equipment is maintained to GMP standard.
Responsible for defining and executing microbiology-specific equipment qualifications, method validations, and continuous process development to ensure constant GMP compliance with regards to CMC, Pharmacopeial monographs, and regulatory guidance.
Responsible for performing routine testing, including but not limited to, sterility, endotoxin, bioburden, mycoplasma, growth promotion & fertility testing, microbial enumeration, microscopy & microbial identification, and electronic system maintenance (data entry).
Responsible for leading and supporting quality-related activities such as investigations, deviations, CAPAs, and Change Controls.
Responsible for leading and supporting GMP documentation creation or revision to ensure assigned projects remain in regulatory compliance, from authoring through to archiving documentation.
Responsible for leading batch certification for Microbiology-related testing; ensuring all associated actions are complete.
Responsible for identifying and implementing LEAN processes and principles within the Microbiology function.
Responsible for leading and supporting the training of all levels within Microbiology relevant to your role, as well as cross-departmental.
Work with external service providers.
Any other duties as required following consultation with the post holder.
The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.
E Essential
Demonstrated skills and competencies
Experience
P Preferred
- Minimum 8 years experience within a microbiology laboratory, without a BSc/MSc degree, OR
- Minimum of 5 years experience within a microbiology laboratory, with a BSc/MSc degree, OR
- Minimum of 2 years experience within a microbiology laboratory, with a microbiology-related PhD.
Qualifications
- BSc/MSc in Life Sciences / Microbiology-related field. [P]
Skills/Specialist Knowledge
Manufacturing Process:
- Full knowledge and understanding of aseptic processing in sterile manufacturing. [E]
- Knowledge and understanding of microbiological assay limitations in both design and interpretation of results. [E]
- Knowledge and understanding of microbiological sampling requirements within ATMP/Vector manufacture, with understanding of CMC and regulatory compliance. [E]
- Excellent understanding of and familiarity with GMP regulations. (E)
- Must meet the requirements of working in a cleanroom/ aseptic environment [E]
QC Process Knowledge
- SME-level knowledge and understanding of at least [1] analysis method. [E]
- Microbiological analysis, including method and process validation within a Pharma/Biotechnology/ATMP GMP laboratory. [E]
- Full knowledge and understanding of the assay or test principles, including pharmacopeial monographs and regulatory guidance. [E]
- Full knowledge and understanding of aseptic technique and practices within a Microbiology laboratory to maintain asepsis. [E]
QC Instrumentation
- Detailed understanding of the GMP equipment onboarding process (URS/DQ/IOPQ). [E]
GxP Documentation
- Full knowledge and understanding of the ALCOA principles, data integrity, and document management within the GMP Pharma/Biotechnology/ATMP industry. [E]
- Detailed understanding of GMP and associated QMS records including SOPs, Worksheets, Logbooks, laboratory investigations, EM investigations, deviations, CAPAs, and Change Controls. [E]
General
- Extensive previous experience of working in a busy laboratory environment and with various level of scientists. (E)
- Highly Proficient in MS Word, Excel, Power Point, DOE and any other relevant applications. (E)
- Highly flexible, self-motivated, and extremely committed personality to deliver within timelines. (E)
- Ability to present results clearly and logically to wider audience. (E)
- Highly experienced in project and timeline planning with ability to deliver within fast-paced environment. (E)
- Great ability to identify and implement solutions with minimal direction. (E)
- Demonstrated experience in mentorship, supervision, and management of experienced members of team. (P)
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