16 days old

Process Development Sr Associate

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115221200
Amgen

Job ID: R-87165
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Process Development Senior Associate - Attribute Sciences (analytical) to join our team and work from our beautiful Amgen's Thousand Oaks, CA campus. This position will be within our Pre-Pivotal Attribute Science Synthetics group in Process Development.

The focus of this position is on analytical testing and analytical method development to advance Amgen's portfolio. The successful candidate will work cross-functionally and across sites while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline.

Key Responsibilities:

Perform testing in both non-GMP and GMP environments for drug substance and drug product process development and for release of clinical material

Perform instrument maintenance and basic trouble shooting

Develop skills and knowledge to perform method development, validation, troubleshooting and transfer in the Pre-Pivotal environment for both drug substance and drug product

Maintain good understanding of cGMP principles and follow compliance requirements for GMP activities.

Timely notebook keeping; authoring reports, methods, presentations, and other technical documents for record keeping and facilitation of decision making

Practice good time management and prioritization when necessary

Work in team, practice good laboratory housekeeping and ensure safety

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of relevant scientific or industry experience

Preferred Qualifications:

Master's degree and 2+ years of experience in Chemistry, Biochemistry, Pharmaceutical, Biotech, Life Sciences or Chemical Engineering industry

Background in analytical method development, organic chemistry, physical chemistry, and formulation development.

Understanding and hands-on experience with chromatographic techniques, such as liquid chromatography and gas chromatography, as applied to pharmaceutical development.

Understanding and hands-on experience with dissolution techniques for solid oral dosage forms.

Experiences in analytical technologies, such as mass spectrometry (MS), UV, FTIR and titrations

Experience to work with automation, data processing and data management systems related to analytical techniques

Familiar with cGMP regulations and practices.

Excellent written and oral communication skills

Demonstrated abilities in problem solving and multi-tasking

Ability to quickly adapt to a dynamic and fast-paced work environment.

Self-motivation for learning and growth

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.

PI115221200

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87165<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Process Development Senior Associate - Attribute Sciences (analytical) to join our team and work from our beautiful Amgen's Thousand Oaks, CA campus. This position will be within our Pre-Pivotal Attribute Science Synthetics group in Process Development.<br><br>The focus of this position is on analytical testing and analytical method development to advance Amgen's portfolio. The successful candidate will work cross-functionally and across sites while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline.<br><br>Key Responsibilities:<br><br>Perform testing in both non-GMP and GMP environments for drug substance and drug product process development and for release of clinical material<br><br>Perform instrument maintenance and basic trouble shooting<br><br>Develop skills and knowledge to perform method development, validation, troubleshooting and transfer in the Pre-Pivotal environment for both drug substance and drug product<br><br>Maintain good understanding of cGMP principles and follow compliance requirements for GMP activities.<br><br>Timely notebook keeping; authoring reports, methods, presentations, and other technical documents for record keeping and facilitation of decision making<br><br>Practice good time management and prioritization when necessary<br><br>Work in team, practice good laboratory housekeeping and ensure safety<br><br><b><b>Basic Qualifications:</b></b><br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of relevant scientific or industry experience<br><br><b><b>Preferred Qualifications:</b></b><br><br>Master's degree and 2+ years of experience in Chemistry, Biochemistry, Pharmaceutical, Biotech, Life Sciences or Chemical Engineering industry<br><br>Background in analytical method development, organic chemistry, physical chemistry, and formulation development.<br><br>Understanding and hands-on experience with chromatographic techniques, such as liquid chromatography and gas chromatography, as applied to pharmaceutical development.<br><br>Understanding and hands-on experience with dissolution techniques for solid oral dosage forms.<br><br>Experiences in analytical technologies, such as mass spectrometry (MS), UV, FTIR and titrations<br><br>Experience to work with automation, data processing and data management systems related to analytical techniques<br><br>Familiar with cGMP regulations and practices.<br><br>Excellent written and oral communication skills<br><br>Demonstrated abilities in problem solving and multi-tasking<br><br>Ability to quickly adapt to a dynamic and fast-paced work environment.<br><br>Self-motivation for learning and growth<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/nVrXWKtYq5AmuExahwO6l"> <p>PI115221200</p>

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Posted: 2019-11-06 Expires: 2019-12-07

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Process Development Sr Associate

Amgen
Thousand Oaks, CA 91360

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