Pillar5 Pharma Inc., an industry leading Canadian CDMO specializing in off-the-shelf sterile pharmaceuticals for the North American market, has an opening for a Microbiology Analyst at our Arnprior, ON location. Reporting to the Microbiology Team Lead, your main objective will be to prepare and perform microbial analysis on raw materials, finished products, blends, bulk products and stability samples as per the procedure and according to specified timelines.
Responsibilities:
Execute and independently perform routine analysis: Microbial Enumeration Test, Membrane Filtration (water system and bioburden), Microbial Identification, AET, Antibiotic Assay (Cylinder-Plate and Turbidimetric), Growth Promotion and Media Properties Test, Total Viable Spore Count and Colorimetric Assays.
Recording, analyze, and interpret environmental monitoring results from the aseptic processing area and the non- aseptic processing areas.
Preparing and evaluate microbiological media, standards, controls, and rinse solutions.
Preparing and maintenance of frozen stock cultures.
Preparation of sterility test samples.
Water sampling and environmental monitoring of the NAPA.
Perform gown qualification training for the Aseptic Processing Area personnel and support personnel.
Maintenance of laboratory equipment, housekeeping, dishes, and inspection readiness.
Assist in laboratory failure investigations.
Experience in computer programs (Word, Excel, and LIMS)
Maintain records and notebooks in good order. Prepare reports and record data in timely manner.
Qualifications and Requirements:
Bsc. in Microbiology (4 year) with related experience in a pharmaceutical manufacturing environment. Other combinations of technical training and experience may be considered.
Minimum of 1-3 years of relevant laboratory work experience required.
Able to work well under pressure and balance conflicting demands of high volume versus the quality of results.
Sound knowledge of Microbiology test methods (USP) and aseptic techniques.
Knowledge of gowning and aseptic practices in Aseptic Processing Areas.
Knowledge of Six Sigma tools would be an asset.
Knowledge of Biosafety practices and tools in a containment level 2 laboratory.
Ability to calculate and perform serial dilutions.
Demonstrated ability to work independently and within a team environment.
Demonstrated planning, organizational, and time management skills.
Experience in routine maintenance and operation of autoclaves, biological safety cabinets, centrifuges, microscope, pH meters, plate readers and automatic pipettors.
Demonstrate excellent documentation practices and maintenance of records.
Excellent oral and written communication skills.
Experience and knowledge of computerized information systems (LIMS).
Understanding of Good Laboratory Practices, Good Manufacturing Practices and the Canadian Biosafety
Why Us?
We are a proud Canadian company in a small town, and we care about our shared environment.
We provide a safe and clean work environment.
We offer flexible work policies and encourage strong work-life balance.
We encourage and drive personal and professional development within our organization.
We have expanded our operations with a new facility, providing the opportunity for growth and new challenges.
We thank all applicants for their interest, however, only candidates selected for interviews will be contacted.
Pillar5 Pharma celebrates diversity and are proud to be an equal opportunity employer. We are committed to an inclusive environment for all employees and applicants. Upon request, accommodations due to a disability are available throughout the recruitment process.
Pillar5 Pharma Inc. is an industry leading Canadian CDMO & with strong capabilities in sterile ophthalmic manufacturing. The company is currently the only CDMO with multi-dose preservative free (MDPF) solutions for the North American market. Pillar5 Pharma’s award-winning manufacturing facility was built by Pfizer in 1956 and has been instrumental to their company’s continued growth and success. Since 2009, Pillar5 has doubled its sterile ophthalmic manufacturing capabilities, undergone significant plant expansion, and seen revenue more than double. Following March 2021, Pillar5 became one of 14 specialized and complementary companies within the ANJAC family, a French family-owned industrial group and a partner to beauty & wellness brands and pharmaceutical laboratories.