1 job found in lexington, massachusetts

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    • lexington, massachusetts
    • contract
    • US$50.00 - US$53.88, per hour, $50.00 - 53.88 per hour
    • 9 to 5
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! location: Lexington, Massachusettsjob type: Contractsalary: $50.00 - 53.88 per hourwork hours: 9 to 5education: Bachelors responsibilities:OBJECTIVES/PURPOSE- Project Management of Stability Studies for Drug Products, Drug Substances and Intermediates as well as associated Data Evaluations and Documentation- Assignment and continuous Monitoring of product shelf life- Authoring of technical documents for regulatory submissionsACCOUNTABILITIES- Management of stability studies for assigned products- Generation of stability protocols and stability reports (e.g. final reports, PQRs, annual reports)- Authoring and review of stability sections for regulatory submissions- Writing and review of responses for health authority requests and communication with regional authorities- Statistical analysis and evaluation of stability data (e.g. Shelf Life or Internal Alert Limit determination)- Subject matter expert for stability during audits and inspections- Stability OOS/OOT investigation ownership- Evaluation of transport temperature excursions- Performing change request assessments with regard to stability- Generation and review of SOPs and forms for processes associated with stability study management- Implementation of Global Standards and Processes for Stability Study Management- Implementation of Continuous Improvement Projects within the Department- Coordination and Management of stability activities at external contract organizations (CMO, CTL, CRO) including procurement activities- Other Responsibilities and Projects as assigned.DIMENSIONS AND ASPECTSTechnical/Functional (Line) Expertise- Experienced in GMP regulations and compliance requirements- Knowledge and understanding of ICH and other regulatory requirements.- Knowledge and ability to author stability CMC sections and regulatory responses- Experience with various quality systems (e.g. investigations, CAPAs and change controls)- Fluent in English (written and oral)- Good GDP skills- Technical writing skills.- Conducts work in compliance with cGMPs, safety and regulatory requirements- Relevant experience with pharmaceutical pipeline products and CMC aspects of regulatory filings.Innovation- Scientific knowledge in protein / plasma / antibody chemistry / small molecule products- Good analytical and problem solving abilities- Experienced in working with global teams qualifications:- Typically requires Bachelor/ Master Degree in Science or Engineering or several years of Experience in pharmaceutical Industry Science related degree is preferred- Team Player- Good Communication Skills- Seeks and considers feedback- Global Cultural Awareness- Ability to prioritize work and multitask.ADDITIONAL INFORMATION- Limited to no travel expected. Travel between sites may be required. skills: 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.
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! location: Lexington, Massachusettsjob type: Contractsalary: $50.00 - 53.88 per hourwork hours: 9 to 5education: Bachelors responsibilities:OBJECTIVES/PURPOSE- Project Management of Stability Studies for Drug Products, Drug Substances and Intermediates as well as associated Data Evaluations and Documentation- Assignment and continuous Monitoring of product shelf life- Authoring of technical documents for regulatory submissionsACCOUNTABILITIES- Management of stability studies for assigned products- Generation of stability protocols and stability reports (e.g. final reports, PQRs, annual reports)- Authoring and review of stability sections for regulatory submissions- Writing and review of responses for health authority requests and communication with regional authorities- Statistical analysis and evaluation of stability data (e.g. Shelf Life or Internal Alert Limit determination)- Subject matter expert for stability during audits and inspections- Stability OOS/OOT investigation ownership- Evaluation of transport temperature excursions- Performing change request assessments with regard to stability- Generation and review of SOPs and forms for processes associated with stability study management- Implementation of Global Standards and Processes for Stability Study Management- Implementation of Continuous Improvement Projects within the Department- Coordination and Management of stability activities at external contract organizations (CMO, CTL, CRO) including procurement activities- Other Responsibilities and Projects as assigned.DIMENSIONS AND ASPECTSTechnical/Functional (Line) Expertise- Experienced in GMP regulations and compliance requirements- Knowledge and understanding of ICH and other regulatory requirements.- Knowledge and ability to author stability CMC sections and regulatory responses- Experience with various quality systems (e.g. investigations, CAPAs and change controls)- Fluent in English (written and oral)- Good GDP skills- Technical writing skills.- Conducts work in compliance with cGMPs, safety and regulatory requirements- Relevant experience with pharmaceutical pipeline products and CMC aspects of regulatory filings.Innovation- Scientific knowledge in protein / plasma / antibody chemistry / small molecule products- Good analytical and problem solving abilities- Experienced in working with global teams qualifications:- Typically requires Bachelor/ Master Degree in Science or Engineering or several years of Experience in pharmaceutical Industry Science related degree is preferred- Team Player- Good Communication Skills- Seeks and considers feedback- Global Cultural Awareness- Ability to prioritize work and multitask.ADDITIONAL INFORMATION- Limited to no travel expected. Travel between sites may be required. skills: 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.

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