Proclinical is currently recruiting for a Pharmaceutical Microbiologist with a pharmaceutical company located in Collegeville, PA. Successful candidate will provide scientific support for pilot plant facilities and project teams to ensure data meet compendial and quality standards.
- Co-ordinate or perform appropriate scientific testing to support release of finished sterile and non-sterile products or testing of stability samples for clinical product manufacture.
- Review microbiological test results (bioburden, sterility, endotoxin) from in house or contract microbiological testing labs for completeness, accuracy, and quality, in addition to assessing trends to draw conclusions.
- Work with UP microbiology team to define microbiological control strategies for drug products (both API and Drug Product formulations).
- Maintain partnership with clinical manufacturing and product development teams to provide timely and high-quality data and service.
- Develop and propose specifications, sampling instructions, test methods and other Quality Control procedures.
- Maintain training records and familiarity with current SOPs and controlled documents.
- Proactively seek assistance from other scientists to solve problems.
- Work to GMP standards as appropriate.
- Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.
Skills and Requirements:
- Bachelor's degree in a scientific or technical discipline (i.e. Pharmaceutical Sciences, Microbiology, Biology) with preference to having pharmaceutical experience in method development, validation and testing of API/drug products.
- General compendial knowledge of USP Microbiology.
- Experience with GMP laboratory operations and FDA regulations
- Excellent verbal and written communication skills.
- Ability to prioritize and organize tasks.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.