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Process Development Principal Scientist- Biological and Structural Characterization - Cambridge, MA, United States - Amgen
Description
Career CategoryProcess DevelopmentJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career.
How will you put your skills, experience, and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Process Development Principal ScientistLiveWhat you will doLet's do this. Let's change the world.
In this vital role you will be responsible for developing, qualifying, and transferring state-of-the-art and fit-for-purpose quantitative potency and biological characterization assays and supporting sample testing and regulatory submissions.
Responsibilities include:
Developing state-of-the-art and fit-for-purpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigationsManaging a team or teams of bioassay staff that contribute to the achievement of department and project objectivesPreparing technical reports for investigations, product and impurity characterization, and regulatory submissionsGenerating and analyzing analytical data to support: product development investigations, and regulatory submissionsCommunicating to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation, and data interpretation.
Designing and implementing analytical projects involving method development, qualification, and transfer with minimal directionProviding critical evaluation of analytical data and results to support product development (for Process Development, Quality, etc.), investigations and regulatory submissions and assessing their impact to these programsLeading the development of key scientific strategies and determining objectives within the functionWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients.
The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:
Bachelor's degree and 7 years of scientific experienceORMaster's degree and 5 years of scientific experienceORDoctorate degree in Cell Biology, Molecular Biology, Immunology, Biochemistry, or similar fields and 2 years of scientific experience
Preferred Qualifications:
Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteinsExpertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer)Expertise 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 linesInnovation – supports new ideas and initiativesDetail oriented and excellent documentation skillsExperience with automated liquid handling preferredClient orientation– establishes effective and responsive relationships with all clients; ensures value is deliveredCommunication and interpersonal skills – communicates effectively with others, using appropriate diplomacy and sensitivity; make others feel respected, valued and understood; works well in teamsDemonstrates key leadership skills such as agility, adaptability, inspiring, and innovationThriveWhat 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.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear.
Join 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.Salary Range136,662.00 USD - 164,812.
00 USDSummaryLocation:
US - Massachusetts - CambridgeType: Full time
