26 days old

Senior Associate Scientist, Process Development (Analytical)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117557075
Amgen

Job ID: R-91966
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Senior Associate Scientist to join our Process Development team. This position will be based out of Thousand Oaks, California and will report to the Process Development Scientist of Pre-Pivotal Attribute Sciences within Process Development.

A largely laboratory-based position where the focus will be on driving cutting-edge analytical support and technology development impacting process and product development teams across Amgen's portfolio. Work cross-functionally and across R&D sites while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline.

In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world.

Key Responsibilities for this role are as follows:
  • Analytical method development, validation and trouble-shooting for small molecule drug substances and drug products using LC/UPLC, GC, spectroscopic and dissolution techniques
  • Perform development sample analysis for process development
  • Perform testing following cGMP requirements for release and stability studies of drug substance and drug product
  • Perform basic instrument maintenance and basic trouble-shooting
  • Document, review results and maintain electronic laboratory notebooks
  • Author, review and data verify technical documents, and presentations
  • Keep updated with instrument automation/software systems, and other scientific and document systems relevant for success in this role
  • Interact with drug substance, drug product and other clients for project needs, and communicating progress
  • Assist in training other staff members in area of expertise
  • Participate in method transfer and method trouble shooting at external testing labs, including reviewing data and report from external partners
  • Work and adapt in a fast-paced and dynamic environment
  • Follow Good Laboratory Practices (GLPs) and contribute to maintaining a safe work environment


Basic Qualifications:

  • Master's degree and 3 years of Scientific experience


OR

  • Bachelor's degree and 5 years of Scientific experience


Preferred Qualifications:
  • Master's degree in Analytical Chemistry, Physical, Pharmaceutical, Life Sciences or Engineering
  • 5+ years in the pharmaceutical or biotech industry post Master's degree
  • Strong expertise in analytical method development and method validation for small molecule drug substances and drug products including method trouble shooting, with minimal supervision
  • Extensive experiences and solid theoretical understanding with chromatographic techniques (Liquid chromatography, gas chromatography, ion chromatography), titrations, vibrational spectroscopy (FTIR and UV), and dissolution techniques, including basic instrument trouble shooting
  • Strong technical aptitude for the identification, development, and implementation of novel analytical technologies, such as Mass spectrometry (MS), NMR, Vibrational spectroscopy
  • Familiarity with automation and implementing data management systems; efficient to compile and communicate complex data-sets in a manner in which facilitates informed decision-making
  • Experienced in drug substance and drug product manufacture process support
  • Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
  • Strong abilities in trouble-shooting, problem solving, and multi-tasking in support of process chemistry and formulation efforts at the pivotal phase of development


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

PI117557075

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91966<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Senior Associate Scientist to join our Process Development team. This position will be based out of Thousand Oaks, California and will report to the Process Development Scientist of Pre-Pivotal Attribute Sciences within Process Development.<br><br>A largely laboratory-based position where the focus will be on driving cutting-edge analytical support and technology development impacting process and product development teams across Amgen's portfolio. Work cross-functionally and across R&D sites while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline.<br><br>In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world.<br><br>Key Responsibilities for this role are as follows:<br><ul><li>Analytical method development, validation and trouble-shooting for small molecule drug substances and drug products using LC/UPLC, GC, spectroscopic and dissolution techniques</li><li>Perform development sample analysis for process development</li><li>Perform testing following cGMP requirements for release and stability studies of drug substance and drug product</li><li>Perform basic instrument maintenance and basic trouble-shooting</li><li>Document, review results and maintain electronic laboratory notebooks</li><li>Author, review and data verify technical documents, and presentations</li><li>Keep updated with instrument automation/software systems, and other scientific and document systems relevant for success in this role</li><li>Interact with drug substance, drug product and other clients for project needs, and communicating progress</li><li>Assist in training other staff members in area of expertise</li><li>Participate in method transfer and method trouble shooting at external testing labs, including reviewing data and report from external partners</li><li>Work and adapt in a fast-paced and dynamic environment</li><li>Follow Good Laboratory Practices (GLPs) and contribute to maintaining a safe work environment</li></ul><br><br>Basic Qualifications:<br><br><ul><li>Master's degree and 3 years of Scientific experience</li></ul><br><br>OR<br><br><ul><li>Bachelor's degree and 5 years of Scientific experience</li></ul><br><br>Preferred Qualifications:<br><ul><li>Master's degree in Analytical Chemistry, Physical, Pharmaceutical, Life Sciences or Engineering</li><li> 5+ years in the pharmaceutical or biotech industry post Master's degree </li><li>Strong expertise in analytical method development and method validation for small molecule drug substances and drug products including method trouble shooting, with minimal supervision</li><li>Extensive experiences and solid theoretical understanding with chromatographic techniques (Liquid chromatography, gas chromatography, ion chromatography), titrations, vibrational spectroscopy (FTIR and UV), and dissolution techniques, including basic instrument trouble shooting</li><li>Strong technical aptitude for the identification, development, and implementation of novel analytical technologies, such as Mass spectrometry (MS), NMR, Vibrational spectroscopy</li><li>Familiarity with automation and implementing data management systems; efficient to compile and communicate complex data-sets in a manner in which facilitates informed decision-making</li><li>Experienced in drug substance and drug product manufacture process support</li><li>Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment</li><li>Strong abilities in trouble-shooting, problem solving, and multi-tasking in support of process chemistry and formulation efforts at the pivotal phase of development</li></ul><br><br>We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.<br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<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/eo2ax4tNnmrNcjxYhdXDl"> <p>PI117557075</p>

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Posted: 2020-01-29 Expires: 2020-02-29

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Senior Associate Scientist, Process Development (Analytical)

Amgen
Thousand Oaks, CA 91360

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