25 days old

Process Development Principal Scientist

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117761606
Amgen

Job ID: R-92988
Location: Thousand Oaks, CA, US 91360

JOB SUMMARY:

The Pivotal Synthetic Drug Product group of the Drug Product Technologies (DPT) department of Amgen at Thousand Oaks, CA is seeking an enthusiastic, highly motivated, mature, and team-oriented scientist for the position of Principal Scientist.

In this leadership role, the Principal Scientist will serve as Drug Product Team Lead (DPLT) providing creative functional area strategies and formulation expertise during the development of pivotal and commercial ready programs. This Amgen leader will lead cross-functional and/or multi-disciplinary teams and guide junior scientists towards innovative and fast paced development approaches. The individual will effectively interface within the DPT department and with other Amgen functions, such as Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, Biostatistics, etc. In addition, proactive and effective interaction with external industrial (eg. IQ consortium) and academic groups (eg. University consortia) is expected.

Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas

Basic Qualifications:

Doctorate degree and 3 years of scientific experience

OR

Master's degree and 6 years of scientific experience

OR

Bachelor's degree and 8 years of scientific experience

Preferred Qualifications:

Ph.D. in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering, or other relevant scientific field with 10+ years of experience in pharmaceutical industry with emphasis, but not limited to oral solid dosage forms

In depth understanding of unit operations for the manufacture of oral solid dosage forms

Experience in optimization and scale-up studies using QbD principles

Experience interacting with Contract Research/Manufacturing Organizations

Experience as Formulation Development lead serving on interdisciplinary and multidisciplinary teams

Experience in authoring regulatory documentation (IND, MA, etc.) and interacting with regulatory authorities

Experience on parenteral and or pediatric formulations, and unique dosage forms

Design, execution and conduction of independent formulation research

A solid publication record

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.

PI117761606

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92988<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/><b>JOB SUMMARY:</b><br><br>The Pivotal Synthetic Drug Product group of the Drug Product Technologies (DPT) department of Amgen at Thousand Oaks, CA is seeking an enthusiastic, highly motivated, mature, and team-oriented scientist for the position of Principal Scientist.<br><br>In this leadership role, the Principal Scientist will serve as Drug Product Team Lead (DPLT) providing creative functional area strategies and formulation expertise during the development of pivotal and commercial ready programs. This Amgen leader will lead cross-functional and/or multi-disciplinary teams and guide junior scientists towards innovative and fast paced development approaches. The individual will effectively interface within the DPT department and with other Amgen functions, such as Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, Biostatistics, etc. In addition, proactive and effective interaction with external industrial (eg. IQ consortium) and academic groups (eg. University consortia) is expected.<br><br>Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 3 years of scientific experience<br><br>OR<br><br>Master's degree and 6 years of scientific experience<br><br>OR<br><br>Bachelor's degree and 8 years of scientific experience<br><br><b>Preferred Qualifications:</b><br><br>Ph.D. in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering, or other relevant scientific field with 10+ years of experience in pharmaceutical industry with emphasis, but not limited to oral solid dosage forms<br><br>In depth understanding of unit operations for the manufacture of oral solid dosage forms <br><br>Experience in optimization and scale-up studies using QbD principles<br><br>Experience interacting with Contract Research/Manufacturing Organizations<br><br>Experience as Formulation Development lead serving on interdisciplinary and multidisciplinary teams<br><br>Experience in authoring regulatory documentation (IND, MA, etc.) and interacting with regulatory authorities<br><br>Experience on parenteral and or pediatric formulations, and unique dosage forms<br><br>Design, execution and conduction of independent formulation research<br><br>A solid publication record<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/BXbWxnUMga5zfpB2iRrwl"> <p>PI117761606</p>

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Posted: 2020-02-04 Expires: 2020-03-06

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Process Development Principal Scientist

Amgen
Thousand Oaks, CA 91360

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