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Scientist Drug Substance Technologies

Company name
Amgen, Inc.

Cambridge, MA

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Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science\u00e2\u20ac\u2122s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people\u00e2\u20ac\u2122s lives.JOB SUMMARY Amgen\u00e2\u20ac\u2122s Process Development organization is seeking a highly qualified candidate to join the Pivotal Drug Substance Technologies team responsible for developing innovative solutions to prepare our small molecule and hybid drug candidates.The scientist will contribute to drug substance development teams, providing continuous manufacturing expertise and devising new technologies to enable synthetic process design.SCIENTIFIC\/TECHNICALChampions innovative applications of integrated continuous manufacturing, synthetic flow-chemistry, process analytical technologies (PAT), automation and data analysis.Provides significant contributions to drug substance development teams (e.g., product and process development teams, product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, etc.Serves as a technical expert and keeps current in organic chemistry and applications of continuous manufacturing in pharmaceutical development including literature and technology development.Improves the technical or scientific capabilities of the department and routinely answers questions on or resolves scientific\/technical issues.Collaborates in cross-functional CMC teams to develop Amgen\u00e2\u20ac\u2122s pipeline.Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen\u00e2\u20ac\u2122s regulatory filings.Deliver processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment.TEAM EXPERIENCEEffectively participates on drug substance development teams as a team member.Works effectively in a multi-disciplinary team of chemists, engineers and attribute scientists.Collaborates with other scientists and professionals outside the department.COMMUNICATIONIndependently prepares technical reports and contributes to regulatory filings and patents.Conveys information and makes recommendations on scientific issues to senior management.Communicates effectively in individual and group situations.LEADERSHIP AND INFLUENCEPlans, coordinates and conducts work associated with process development studies for batch and continuous processes.Negotiates and collaborates interdepartmentally.Participates in departmental committees to address departmental and interdepartmental problem solving, and activities.DECISION MAKING AND JUDGMENTInforms and consults management appropriately.Basic QualificationsDoctorate degree or Doctorate degree by October 2018ORMaster's degree and 4 years of scientific experienceORBachelor\u00e2\u20ac\u2122s degree and 6 years of scientific experiencePreferred QualificationsDoctorate degree in Organic Chemistry, Medicinal Chemistry or Synthetic ChemistryPost-doctoral research experienceTrack record of demonstrated scientific accomplishments in the field of organic chemistryAbility to champion new technologiesExperience in the pharmaceutical \/ biotech or related industry that includes participation and contribution to scientific project teamsExperience with integrated continuous manufacturing appraoches to synthetic moleculesExperience with flow-chemistry as an enabling technology to develop new, safer and more green\/sustainable processesFamiliarity with common industrial unit operations including crystallization (batch and continuous mode), filtration and dryingFamiliarity with the use of design of experiments (DoE) and Process Analytical Technology (PAT) techniquesFamiliarity with laboratory automation, data analysis and visualization techniques and toolsFamiliarity with Environmental Health and Safety expectations for chemical laboratoriesFamiliarity with current Good Manufacturing Practices for preparing drug substances and intermediatesDemonstrated ability to effectively work in a fast-paced team environmentExcellent interpersonal, presentation, written and verbal skillsKnowledge of basic office software including Microsoft Word, Excel, and PowerPointAmgen 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.

Company info

Amgen, Inc.
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Company Profile
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.

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