Job Information
Actalent Pharmaceutical Microbiologist in Shawnee Mission, Kansas
Pharmaceutical Microbiologist - Paying up to $48/hr.
Description :
The microbiologist would work in the microbiology Quality Control laboratory performing method feasibility, development, and validation of all compendial microbiology related methods for new product transfers to this site.
The position will report directly to the analytical development manager or quality control manager and work in close collaboration with the microbiology Quality Control team and project team, periodically interfacing directly with external customers as a technical subject matter expert.
Active projects include the development and validation on-site of compendial based microbiological methods for five sterile injection, two non-sterile liquid suspension, and one solid oral dose veterinary pharmaceutical drug product and their associated APIs and raw materials.
The microbiologist is expected to be proficient in ELISA methodology for pharmaceutical applications.
Support additional projects in the near future.
The candidate would be trained by experienced microbiologists on SOPs and equipment operation governing the method development and validation work, and would follow templates for document authoring.
Skills & Qualifications :
Bachelor’s degree in a scientific field with 4+ years of experience
Prior work in a cGMP FDA 21CFR210/211 pharmaceutical manufacturing quality control role
Method development and validation protocol authoring, execution, and report authoring
Sterility USP <71> testing and method validation experience of liquid injection products and sterile suspensions, with preferred experience testing in an isolator
Endotoxin USP <85> testing and method validation experience of liquid injection products, raw materials, and sterile suspensions using kinetic chromogenic or turbidimetric methods and instrumentation
Microbial Limits Testing USP <61> and <62> testing and method validation experience of non-sterile liquids, pastes, and suspensions and raw materials (solids, liquids) as well as bulk injection solution testing
Subvisible particulate testing per USP <788> by light obscuration (e.x. HIAC) and by microscope
Media growth promotion and microbial identification
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.