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location: Cambridge, Massachusetts
job type: Contract
salary: $60.00 - 68.73 per hour
work hours: 8 to 4
- This is a 9-month contract position within Company's Vaccine Business Unit (VBU) Quality Technical Operations (QTO) organization. Stability and microbiological experience is highly desirable. The position will work closely with internal stakeholders including Quality Assurance, Analytical Development, CMC, and Regulatory Affairs as well as with contract testing laboratories.
- 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.
- 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.
skills: CMC, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.