Process Development Scientist Biological Relevance and Characterization

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Cambridge, Massachusetts

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Sat, 05 Dec 2020 23:59:59 GMT

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Description :
The Biological Relevance and Characterization group assists with the developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency/characterization assays and supporting regulatory submissions. Role Responsibilities – Developing and implementing state-of-the-art and fit-for-purpose analytical methods for release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations – May lead a team of lab associates to accomplish project results – Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions – Generating, analyzing, and interpreting analytical data to support – Participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation – Plans and manages the generation of detailed analytical procedures used for product lot release, stability testing, and/or characterization. this includes timelines, achievements, methodological approaches, encouraged results, and vital resources – Keeping current with the analytical development field including literature and technology development for cutting edge and regulatory driven activities – Crafting and implementing analytical projects involving method development, qualification, and transfer – Provides critical evaluation of analytical data and results to support product development (for Process Development, Quality, etc.), investigations and regulatory submissions Basic Qualifications Master’s degree OR Bachelor’s and 2 years of biotechnology experience in manufacturing, engineering or process development OR Associate’s degree and 2 years of biotechnology experience in manufacturing, engineering or process development OR High school diploma / GED and 2 years of biotechnology experience in manufacturing, engineering or process development Preferred Qualifications – Expertise in cell culture and bioassay development for the quantitative determination of the biological activity of large molecule therapeutics – Expertise in cell-based bioassay development (method optimization, qualification, validation, technical transfer) – Expertise in virology and oncolytic viruses preferable – Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies – Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines – Excellent documentation skills, is detail oriented – Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines preferred – Ability to expand analytical development expertise to a broader level of understanding in pharmaceutical R & D and commercialization – Experience with automation is desirable – Innovation – positive approach to challenges; champions new insights and initiatives; brings out and utilizes others’ creativity to improve unit performance – Client orientation – establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered; works well in teams – Supervise performance and provide adequate feedback through mentoring and effective performance appraisal and development planning – Leadership – supports teamwork and collaboration – Communication – establishes and maintains effective communication mechanisms to keep staff appropriately advised; bridges communication between individuals, units and other organizations as vital Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Join Us If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.