Associate Scientist, Northern/Southern Blotting
Proclinical is currently recruiting for an Associate Scientist for a global pharmaceutical company located in Philadelphia, PA. Successful candidate will perform and direct Genetic Stability assays, especially Southern Blotting, according to and in compliance with current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).
- Conduct and direct assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
- Accurately complete batch records and other required documentation according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
- Demonstrate innovative and independent scientific technical expertise.
- Work with Lab Supervisor in scheduling and coordinating day-to-day laboratory operations.
- Contribute independently to overall scientific rigor through objective laboratory investigation.
- As assigned by Management, supervise personnel and assume all associated responsibilities.
- As assigned by Management, act as Technical Reviewer, Area Manager, or Principal Investigator for assays and assumes all associated responsibilities.
- Demonstrate proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
- Design and independently conduct scientific development projects from inception to completion.
- Conduct critical review of results and report data to Technical Reviewer, Area Manager or Principal Investigator.
- Initiate, prepare and revise technical documents and reports.
- Effectively communicate and defend science through written and verbal communication.
- Maintain laboratory notebook and follows all general and laboratory SOPs.
- Perform assays using appropriate laboratory techniques for lab group assigned to.
- Report observations of ongoing tests to Technical Reviewer, Area Manager or Principal Investigator.
- Communicate with supervisor and other colleagues re: daily lab activities.
- Review and sign lab notebooks.
- Provide training on areas of technical expertise and compliance issues relevant to the lab setting and train new personnel in lab procedures.
- Effectively interact with clients as required.
- Document test article information on temperature charts for monitored equipment and gives copy to Quality Assurance as needed.
- Complete all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.)
Skills and Requirements:
- Master's degree with a major in Biological Sciences or science related major or equivalent training and/or experience; 7+ years of relevant experience or equivalent with a Bachelors' degree with commensurate experience.
- Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.
- Knowledge of FDA GLP/ cGMP requirements, FDA PTC guidelines required.
- Knowledge of EU cGMPs highly desirable.
- Ability to write and revise documents. Ability to use judgment in situations for which there are no precedents.
- Experience in GLP and GMP.
- Ability to work under limited supervision and to handle problems of a difficult nature.
- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
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 (+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.