ProClinical is seeking an applicant for the permanent position of Associate Scientist/Study Director (Viral Clearance) based in Philadelphia, Pennsylvania. The Associate Scientist/Study director will perform and direct assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Sufficiently competent in science to serve as Study Director. Assist with training junior staff members as needed. Additionally, the correct applicant must correctly analyze scientific data with accuracy and precision, and be assigned supervisor responsibilities.
- Demonstrate scientific technical expertise in Downstream Purification (Column Chromatography, Nano filtration) by performing client viral clearance processes/assays.
- Effectively communicate and defend science via written and verbal communication.
- Provide training on areas of technical expertise and compliance issues relevant to the lab setting.
- Conduct and direct 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.
- Demonstrate proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
- As assigned by Management, act as Study Director for specific assays and assumes all associated responsibilities.
- Train new personnel in lab procedures.
- Effectively interact with clients as required.
- Schedule lab work.
- Perform assays using appropriate laboratory techniques for lab group assigned to.
- Communicate with supervisor and other colleagues re: daily lab activities.
- May perform supervisor responsibilities if assigned by Management
- Prepares and revises technical documents and reports.
- Reports date changes for testing and other pertinent information to clients via Project Management Department.
- Bachelor’s degree with major in Biological Sciences or science related major or equivalent training and/or experience.
- 4+ years of relevant experience required
- Interpreting and Analyzing data, writing reports
- Nanofiltration experience and Ultra Filtration/Diafiltration experience preferred.
- Specialized training in laboratory techniques used in assigned laboratory is required, specifically Cell Culture, Cell-based assays and qPCR.
- Knowledge of GLP and cGMP guidelines is preferred.
- Ability to use judgment as dictated by complexity of situation.
- Ability to work under limited supervision and to handle problems of a more difficult nature.
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 Mary Jacobs at (+1) 267 477 4800 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.