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Lead Quality Control Analyst

  • Anywhere

Company :
Leica Biosystems

Location :
Marlborough, Massachusetts

Expiry Date :
Sat, 05 Dec 2020 23:59:59 GMT

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Description :
Help us improve access to life-changing therapies that can transform human health We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020. Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services – the pots, pans, soups and sauces they need to work better, faster and safer, leading to better patient outcomes. We are looking for a Lead Quality Control Analyst to work with our expert Quality Control Team focused on GMP manufacturing support to impact our customers and patience across the world. Do you have a passion for Quality Control? Then we would love to hear from you. What you ll do * Design and perform method qualification protocols/experiments in conjunction with the Analytical Development team * Author and review standard test methods and reports. * Maintain lab equipment by following appropriate calibration and maintenance activities. * Able to effectively communicate critical analytical issues and solutions to clients * Participate/Lead technical discussions with clients * Review analytical development reports, assay and process validation reports and other technical documents for technical correctness and regulatory compliance. * Prepare, evaluate, and present data internally to cross-functional teams. * Participate in laboratory audits, as required. * Adhere to site Quality and Safety Policies. Maintains cGMP compliance within their laboratories * Work towards accomplishment of Site Goals. * Conduct technical assessments of deviations and investigations * Accept, complete, and report on assignments within the agreed upon timeframe. * Work with QC Management on lean initiatives and site goals. * Support routine testing for manufacturing runs and stability studies. * Review assay and technical documents as necessary * Perform general lab support activities, including but not limited to, making reagents, equipment maintenance, etc. * Independently executes activities without supervisor guidance. * Leads and coordinates projects with other departments /vendors. * Initiates and owns deviations, CAPAs and change controls within the electronic Quality Management System. * Maintains a safe working environment in the laboratory and participates in safety and compliance inspections * Other duties, as assigned. Who you are * B.S./M.S. in Biochemistry, Chemistry, Molecular Biology, or related biological subject area * Minimum 5+ years of relevant industry experience and lab experience in a GMP setting. * Must have strong knowledge of analytical assay principles and procedures, and related instrumentation. * Individuals must have strong experience in bioassays-cell based assays. * Gene Therapy; AAV, VLPs and viral vectors product experience, * CDMO or CRO experience preferred, but not required. * Experience with analytical methods such as RT-PCR and other gene/protein expression assays, cIEF, CE-SDS, Biacore, HPLC, Western blot and ELISA. * Knowledge and experience with molecular and cell biology, virology and/or immunology. * Strong interpersonal and leadership skills. * Ability to work with others to troubleshoot complex technical and scientific problems while showing sufficient independence in execution and thought processes. * Wide experience working with many different types of proteins, including mAbs, Viral, and complex glycoproteins. * Strong communication skills and enthusiasm to work in a collaborative team environment. * Working knowledge of FDA, EU, ICH guidelines and regulations * Demonstrated knowledge of method qualifications/validations * Ability to efficiently prioritize, manage, and complete multiple projects and tasks in a fast-paced, matrix environment while maintaining flexibility and attention to detail * Proficient in Microsoft Office suite and applications. * Applied knowledge and in-depth understanding of GMP Quality Control systems * Must be proactive, action oriented and have the ability to adapt to a change * Recognized as a technical specialist. Demonstrates an understanding on how method performance impacts the business over time. Who we are Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you ll feel right at home here. If you re flexible, curious and relentless, you ll belong. If you are excited about a global culture, this can be the place to further your career. Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page! Cytiva is global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients. Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.