12 days old

Process Development Senior Scientist

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115253393
Amgen

Job ID: R-86861
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Process Development Senior Scientist to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. The successful candidate will lead a team of Process Development scientists establishing attribute identification (Product Quality Attributes) and methods (Analytical Target Profile) to monitor and characterize attributes for early stage clinical recombinant protein pharmaceuticals; both drug substance and drug product. Duties include managing staff and collaborating with process scientists in a multi-disciplinary team to execute the full scope of analytical methods for process development including; in-process testing, lot release, stability, comparability and protein structure characterization. Other duties include advanced data analyses and attribute trending against acceptance criteria in support of Quality Target Product Profiles.

Additional responsibilities include providing regular updates, documentation, and communication of project results as appropriate, participating in national scientific meetings, and keeping current with thefield of expertise, including literature and technology development. This position is also responsible for providing scientific results that support the generation of publications, patents and regulatory submissions and monitoring and analyzing competitive scientific knowledge from external sources.

Basic Qualifications:

Doctorate degree and 2 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:

Doctorate degree in Chemical / Biochemical Engineering or Structural Biology

Strong background in bioanalytical research and development focusing on method development to study proteins and peptides using novel separation techniques: mass spectrometry and micro-fluidic technology

Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF

Expertise with attribute-based separations, higher order or primary structural analysis of protein and peptide attributes

Experience with complex data analysis and trending, including statistical analysis, setting acceptance criteria in support of process development, process or method transfers, product expiry and comparability studies

Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools

5+ years of scientific experience with early stage products within the biotech industry, 2+ years of direct report supervisory experience

Good problem-solving skills requiring the application of scientific theory

Ability to demonstrate skills in independently determining and developing scientific analysis and solutions, as well as demonstrate strong laboratory work skills to include the design and performance of scientific experiments and interpretation of results

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.

PI115253393

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86861<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Process Development Senior Scientist to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. The successful candidate will lead a team of Process Development scientists establishing attribute identification (Product Quality Attributes) and methods (Analytical Target Profile) to monitor and characterize attributes for early stage clinical recombinant protein pharmaceuticals; both drug substance and drug product. Duties include managing staff and collaborating with process scientists in a multi-disciplinary team to execute the full scope of analytical methods for process development including; in-process testing, lot release, stability, comparability and protein structure characterization. Other duties include advanced data analyses and attribute trending against acceptance criteria in support of Quality Target Product Profiles.<br><br>Additional responsibilities include providing regular updates, documentation, and communication of project results as appropriate, participating in national scientific meetings, and keeping current with thefield of expertise, including literature and technology development. This position is also responsible for providing scientific results that support the generation of publications, patents and regulatory submissions and monitoring and analyzing competitive scientific knowledge from external sources.<br><br>Basic Qualifications:<br><br>Doctorate degree and 2 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>Preferred Qualifications:<br><br>Doctorate degree in Chemical / Biochemical Engineering or Structural Biology<br><br>Strong background in bioanalytical research and development focusing on method development to study proteins and peptides using novel separation techniques: mass spectrometry and micro-fluidic technology<br><br>Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF<br><br>Expertise with attribute-based separations, higher order or primary structural analysis of protein and peptide attributes<br><br>Experience with complex data analysis and trending, including statistical analysis, setting acceptance criteria in support of process development, process or method transfers, product expiry and comparability studies<br><br>Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools<br><br>5+ years of scientific experience with early stage products within the biotech industry, 2+ years of direct report supervisory experience<br><br>Good problem-solving skills requiring the application of scientific theory<br><br>Ability to demonstrate skills in independently determining and developing scientific analysis and solutions, as well as demonstrate strong laboratory work skills to include the design and performance of scientific experiments and interpretation of results<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/8OmgJ8i4aYoJSEVNhwkaB"> <p>PI115253393</p>

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Posted: 2019-11-07 Expires: 2019-12-08

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Process Development Senior Scientist

Amgen
Thousand Oaks, CA 91360

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