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PROCESS DEVELOPMENT SENIOR PRINCIPAL SCIENTIST - CMC TEAM LEAD

Company: Amgen
Location: Cambridge
Posted on: June 6, 2024

Job Description:

Career CategoryProcess DevelopmentJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.Process Development Senior Principal Scientist - CMC Team LeadLiveWhat you will doLet's do this. Let's change the world. In this vital role you will lead a team of scientists focused on the development and qualification of analytical methods, the characterization of protein-based biologic therapies, and supporting process development activities. At Amgen, our mission to serve patients drive all that we do. Come join us to work alongside talented scientific colleagues to advance Amgen's innovative pipeline of therapies.Lead a team of scientists focused on method development and molecule characterization for biologics in late-stage development serving as a mentor, sponsor, and coach with emphasis on people-centered leadership.Serve as the Attribute Sciences team lead on a cross-functional product development team for a biologic in late-stage development with accountability of key decisions, strategies, and deliverables within the analytical sciences space.Author chemistry, manufacturing and controls (CMC) sections in regulatory files, lead the preparation of responses to analytical related questions from health authorities, and support pre-approval inspections.Establish strong partnerships with leaders from multiple functions across Amgen to achieve program deliverables.Expert knowledge in the analysis of protein-based therapies with advanced techniques such as capillary electrophoresis, liquid chromatography, and mass spectrometry.Solid understanding of cGMP / ICH regulations and compendial guidelines with the ability to apply them to analytical development.Ability to develop and implement integrated control strategies for critical quality attributes of biologic therapeutics.Develop and document standard operating procedures, protocols and reports.Develop novel process or approaches to tackle complex problems.Win!What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Senior Principal Scientist professional we seek is a leader with these qualifications.Basic Qualifications:Bachelor's degree and 7 years of scientific / pharmaceutical experience ORMaster's degree and 5 years of scientific / pharmaceutical experience ORDoctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of scientific / pharmaceutical experiencePreferred Qualifications:Degree in analytical chemistry, physical chemistry, biochemistry, pharmaceutical sciences, or related discipline.Strong people-leadership skills and experience with leading a team of direct reports.Excellent laboratory skills with 7+ years of laboratory research or experience in industry. laboratories supporting analysis and characterization of protein therapies.Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including CE-SDS, cIEF / icIEF, HIC, SEC, IEX, RP, HILIC, MS, etc.Expertise with handling, troubleshooting, and maintaining CE and LC instruments.Expertise using CE and LC operation and data analysis software.Experience with data processing and statistical analysis software tools.Ability to independently prioritize, schedule, and lead multiple tasks to meet results.Proven ability to lead complex projects or work packages.Ability to work in a matrix team environment and collaborate effectively.Excellent written and oral communication skills.Experience with use of electronic notebooks.Firsthand experience with method qualifications and transfers.Skilled in phase appropriate GMP compliance and documentation.Thrive!What you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now!for a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.#obesity.Salary Range157,242.00 USD - 182,988.00 USDSummaryLocation: US - Massachusetts - CambridgeType: Full time

Keywords: Amgen, Cambridge , PROCESS DEVELOPMENT SENIOR PRINCIPAL SCIENTIST - CMC TEAM LEAD, Other , Cambridge, Massachusetts

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