Scientist, QC Microbiology
Proclinical is currently seeking a Scientist of QC Microbiology for a global pharmaceutical company located in Philadelphia, PA. Successful candidate will perform and direct assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Acts as Study Director as required.
- Demonstrate innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures as it relates to microbiological and analytical methods.
- Design and independently conduct scientific development projects from inception to completion.
- Effectively communicate and defend science through written and verbal communication.
- Provide training on areas of technical expertise and compliance issues relevant to the lab setting.
- Conduct and direct microbiological assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
- Accurately complete batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
- Prepare protocols, final reports, investigations, and deviations as needed.
- Conduct critical review of results and reports data appropriately.
- As assigned by Management, supervise personnel and assume all associated responsibilities.
- As assigned by Management, act as Study Director, Lab Manager, and/or Principal Investigator for specific assays and assumes all associated responsibilities.
- Effectively interacts with clients.
- Maintain a laboratory notebook for Research & Development activities as required; review and sign laboratory notebooks.
- Follow all general and laboratory SOPs.
- Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Skills and Requirements:
- 8 + years of relevant experience or equivalent for Bachelors', 5+ years for Master's or 3+ PhD degree in Biological Sciences or related field or equivalent experience.
- Strong Technical and Scientific knowledge of microbiological based assays (i.e. Sterility test, bacteriostasis/fungistasis, Bacterial Endotoxin Test, and bioburden testing using the Gram stain.
- Ability to use proficiently advanced laboratory equipment, such as, but not limited to; Bactometers, isolators, BET Kinetic/Chromogenic instruments.
- Effective multi-tasking skills and time management required.
- Ability to evaluate technical data and record data accurately and legibly.
- Ability to accurately and reproducibly perform complex mathematical and statistical calculations.
- Ability to use judgment as dictated by complexity of situations.
- Ability to understand and follow verbal and demonstrated instructions.
- Ability to clearly express and exchange ideas by means of verbal and written communication.
- Ability to work effectively as part of a team and exhibit effective interpersonal skills.
- Ability to work under limited supervision and to handle problems of a difficult nature.
- Proficient in Oral & Written communication skills.
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 Mike Raletz at (+1) 267-428-7770 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.