Join a leading team where your expertise in microbiology will contribute to innovative projects in the pharmaceutical industry. An exciting opportunity awaits in a dynamic environment that values scientific advancement and global project management.
As an ideal candidate, you are a seasoned
Microbiology Expert – Small Molecules
with a strong foundation in both technical microbiology and project management. If you are looking to advance your career while driving impactful initiatives, this role is for you.
* You lead and coordinate
R&D and Lifecycle Management projects
related to microbiology for Small Molecule products.
* You provide
scientific input
on microbiological
method development
,
method qualification/validation
, and
specification setting
for drug products, substances, and raw materials.
* You act as
project lead
for global method transfer and harmonization activities across various sites and external partners.
* You review and approve development reports, qualification/validation reports, and microbiological test methods.
* You coordinate, assess, and follow up on
Change Controls (CCs)
within the microbiology domain.
* You review and approve microbiology-related
specification documents
in alignment with global standards.
* You ensure compliance with all relevant
GMP
, regulatory, and quality requirements.
* You contribute to the continuous improvement of microbiological strategies and foster global alignment within the department.
What are we looking for?
* You hold an
MSc or PhD
degree in
Pharmaceutical Microbiology
,
Life Sciences
, or a related field; or a bachelor's degree with a proven record of relevant experience.
* You have profound knowledge of
pharmaceutical microbiology
, including microbiological test methods, contamination control, and sterility assurance.
* You possess a strong understanding of
pharmaceutical regulations and GxP principles
(FDA, EU, ICH).
* You have proven experience in
project management
within a global or cross-functional environment.
* You are capable of providing
scientific and strategic input
on microbiological method development and specification setting.
* You have experience with
method validation, transfer, and lifecycle management
.
* You are self-motivated, hands-on, and capable of managing multiple priorities efficiently.
* You exhibit excellent stakeholder management and communication skills; able to influence and align in a global matrix organization.
* You have proficiency in
English
(spoken and written) within a professional and scientific context.
* Experience with Trackwise, Docspace, and other quality systems is an asset.
* You have experience working in a
GMP-regulated
pharmaceutical environment.