This role supports
GLP/GMP microbiology analyses within a flagship biotech development program,
leveraging advanced analytical technologies in a flexible, agile, and
collaborative lab environment.
Reporting to the Lab
Manager, Global Analytical Development, this position contributes to the ...
microbiology laboratory by executing GLP and GMP analyses. It interfaces with
QA, GAD (all functions), and manufacturing colleagues to enable smooth analysis
execution, documentation management, and problem solving, while supporting
growth, simplification, and change initiatives to deliver the biotech pipeline
to patients.
Key responsibilities
- Execute tests (Bioburden,
Bacterial Endotoxin Test, Low Bioburden, and Identification) per
established procedures in GLP/GxP environments; deliver results within
defined timelines and complete tasks as assigned. - Review results and perform
data entry using the LIMS. - Conduct Growth Promotion
testing and Method Suitability assessments. - Manage sample/material
receipt and testing, applying quality, EHS, and safety procedures,
guidelines, and standards. - Initiate deviations, OOS
events, or other relevant events; perform lab investigations and
define/implement CAPA as needed. - Write/update microbiology lab
procedures and participate in continuous improvement activities. - Serve as technical referent
during external/internal audits. - Collaborate with colleagues
and other departments while adhering to established standards, including
Good Documentation Practices; escalate events that may impact operations. - Manage own workload and
contribute technically and scientifically by exchanging ideas succinctly;
engage in training programs focused on performance and personal
development; be available for on-call rotations (on-site/off-site) as
needed.
This role supports
GLP/GMP microbiology analyses within a flagship biotech development program,
leveraging advanced analytical technologies in a flexible, agile, and
collaborative lab environment.
Reporting to the Lab
Manager, Global Analytical Development, this position contributes to the
microbiology laboratory by executing GLP and GMP analyses. It interfaces with
QA, GAD (all functions), and manufacturing colleagues to enable smooth analysis
execution, documentation management, and problem solving, while supporting
growth, simplification, and change initiatives to deliver the biotech pipeline
to patients.
Key responsibilities
- Execute tests (Bioburden,
Bacterial Endotoxin Test, Low Bioburden, and Identification) per
established procedures in GLP/GxP environments; deliver results within
defined timelines and complete tasks as assigned. - Review results and perform
data entry using the LIMS. - Conduct Growth Promotion
testing and Method Suitability assessments. - Manage sample/material ...
receipt and testing, applying quality, EHS, and safety procedures,
guidelines, and standards.
Initiate deviations, OOS
events, or other relevant events; perform lab investigations and
define/implement CAPA as needed.Write/update microbiology lab
procedures and participate in continuous improvement activities.Serve as technical referent
during external/internal audits.Collaborate with colleagues
and other departments while adhering to established standards, including
Good Documentation Practices; escalate events that may impact operations.Manage own workload and
contribute technically and scientifically by exchanging ideas succinctly;
engage in training programs focused on performance and personal
development; be available for on-call rotations (on-site/off-site) as
needed.Mostra di più
