Senior Scientist, Vaccine Stability
Proclinical is currently recruiting for a Senior Scientist, Vaccine Stability with a pharmaceutical company located in Cambridge, MA.
- Serve as SME for analytical methods, microbiological methods, and stability for vaccine programs
- Analyze stability data and assess for trends
- Review, enter, verify, and analyze data for GMP release and stability testing of drug substances and drug product materials
- Support OOS/OOT and deviations, and other investigations
- Participate in collaborative interactions with CMO/CTOs
- Review and author GMP documents such as microbial control plans, stability reports, method validation protocols and reports, and other documents for communication with regulatory agencies
- Responsible for technical assessment of methods for compliance to GMP requirements, guidance documents, and analyses of critical quality attributes
- Support supplier audits, review quality agreements, review CoA, and assist with batch disposition
- Other duties as assigned
Skills and Requirements:
- MS with a minimum of 4 years industry experience, or a BS with a minimum of 6 years industry experience
- Knowledge of cGMPs (US and EU) and CMC regulatory requirements, and strong technical expertise in microbiology and microbial methods, and statistical methods for data analyses
- Knowledge and skills in chemistry and biochemistry, and/or microbiology
- Working knowledge of statistical software programs such as JMP is highly desirable
- Excellent oral and written communication skills
- Well organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility
- Good time and project management skills, ability to oversee several projects simultaneously.
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 contact Nikki Ranieri at 215-531-5288 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.