Microbiologist

Microbiologist - 12 Mo Maternity Leave Coverage

On-site in Stevenage Wednesday-Saturday 8am-5:45pm

About our Client:

Our client is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defense mechanisms and eliminate these cells.

What are we looking for:

They are looking for a Microbiologist to provide the essential support to the Microbiology team that allows the release of manufactured product to critically ill patients. Your role will include microbial enumeration, microscopy & identification, sterility testing, bioburden testing, endotoxin testing, mycoplasma testing, 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 to a subject matter expert level.

Key Responsibilities:

• Responsible for supporting the critical operations by ensuring the laboratory and general equipment is maintained to GMP standard, including stock, waste, & sample management, cleaning, calibrations & servicing, and external shipments.

• 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 equipment, method, and process qualification, validation, and/or verification to comply with GMP standards.

• 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 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.

• 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.

Demonstrated skills and competencies:

E – Essential P – Preferred

Experience

• Minimum 5 years’ experience within a microbiology laboratory, without a BSc/MSc degree, OR

• Minimum of 2 years’ experience within a microbiology laboratory, with a BSc/MSc degree, OR

Qualifications

• BSc/MSc in Life Sciences / Microbiology-related field. [P]

Skills/Specialist knowledge:

• Manufacturing Process:

o Detailed knowledge of aseptic processing in sterile manufacturing. [E]

o Understanding of microbiological sampling requirements within ATMP/Vector manufacture, with understanding of CMC and regulatory compliance. [P]

•QC Process Knowledge:

o Microbiological analysis, including method and process validation within a Pharma/Biotechnology/ATMP GMP laboratory. [E]

o Detailed understanding of the assay or test principles, including pharmacopeial monographs and regulatory guidance. [E]

o Detailed understanding of aseptic technique and practices within a Microbiology laboratory to maintain asepsis. [E]

•QC Instrumentation:

o Equipment qualification and general understanding of the GMP onboarding process (URS/DQ/IOPQ). [P]

• GxP Documentation:

o Detailed understanding of the ALCOA principles, data integrity, and document management within the GMP Pharma/Biotechnology/ATMP industry. [E]

o Understanding of GMP and associated QMS records including SOPs, Worksheets, Logbooks, laboratory investigations, EM investigations, deviations, CAPAs, and Change Controls. [E]

• Data Analysis:

o Competent in the entry and interpretation of data, predominantly environmental monitoring, including generating reports and providing assessments. [E]

• General

o Highly Proficient in MS Word, Excel, Power Point, DOE and any other relevant applications. (E)

o Highly flexible, self-motivated, and extremely committed personality to deliver within timelines. (E)

o Extensive previous experience of working in a busy laboratory environment and with various level of scientists. (E)