13 days old

Senior Principal Scientist - Pre-Pivotal Bioprocess Development

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117896432
Amgen

Job ID: R-93030
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Process Development Senior Principal Scientist within our Pre-Pivotal Bioprocess Development team, to be based at our main corporate campus in Thousand Oaks, CA. This Process Development Senior Principal Scientist will report to the Pre-Pivotal Bioprocess Development Director.

Amgen's Drug Substance Technologies (DST) department within the Process Development (PD) organization develops and supports the production of clinical and commercial supply for patients. The Pre-Pivotal Drug Substance Technologies organization develops, characterizes and supports the production of the drug substance manufacturing processes for all early-stage programs across the Amgen portfolio, enabling advancement of programs from pre-clinical through Ph I/II clinical trials.

The Senior Principal Scientist will lead a laboratory-focused group of cell culture and purification scientists who develop robust clinical processes to advance Amgen's biologics pipeline. As part of this opportunity, you will develop strong cross-functional teams and mentor junior staff in career development. The scope of work and responsibility span protein construct selection, clinical process development, support of technology transfer, authoring regulatory Chemistry Manufacturing Control (CMC) documents, and interacting with regulatory agencies. In addition, you will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency.

Key responsibilities:
  • Supervise a team that provides large molecule candidate selection, robust clinical upstream and downstream processes and characterization, and enables successful global regulatory filings.
  • Independently author technical reports, regulatory filings, patents, peer reviewed publications, and actively participates in groundbreaking scientific conferences.
  • Drive technical strategies, conveys information and makes recommendations on scientific issues to senior management.
  • Develop technology to deliver multi-kilogram quantities of drug substance candidates in a safe, practical and efficient manner.
  • Provide meaningful contributions to drug substance development teams (e.g., product, process development, and product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, and project strategies.
  • Serve as a technical expert and keeps current in relevant literature and related technology with a track record of successful application of said technology complying to current and emerging regulatory requirements (e.g., FDA, EMA, ICH)
  • Work cross-functionally to author CMC regulatory documents and documentation in support of Amgen's regulatory filings.
  • Develop processes amenable to cGMP operation and leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity for batch and continuous processes.
  • Ensure that safe laboratory practices are followed.
  • Provides mentoring and expertise to less-experienced staff.
  • Achieve work in a matrix organization through others who may or may not report directly to them, internally or externally.
  • Motivate, develop, and coach staff while promoting team collaboration.


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
  • Doctorate in Biological Science discipline or Chemical Engineering with 6+ years of experience
  • Expertise and experience in mammalian cell culture, cell sciences, and protein purification
  • Extensive experience in development and/or support of biomanufacturing processes, including process scale-up and GMP production
  • Experience in CMC clinical and commercialization process development
  • Leadership of a lab group or leadership experience of functional or cross-functional project teams
  • Proven results from leadership opportunities
  • Track record of innovation and implementation of new technologies
  • Experience in authoring IND sections and interaction with regulatory agencies


Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.

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 focuses on areas of high unmet medical need and uses 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.

PI117896432

<b>Amgen</b><br/><br/><b>Job ID: </b>R-93030<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Process Development Senior Principal Scientist within our Pre-Pivotal Bioprocess Development team, to be based at our main corporate campus in Thousand Oaks, CA. This Process Development Senior Principal Scientist will report to the Pre-Pivotal Bioprocess Development Director.<br><br>Amgen's Drug Substance Technologies (DST) department within the Process Development (PD) organization develops and supports the production of clinical and commercial supply for patients. The Pre-Pivotal Drug Substance Technologies organization develops, characterizes and supports the production of the drug substance manufacturing processes for all early-stage programs across the Amgen portfolio, enabling advancement of programs from pre-clinical through Ph I/II clinical trials.<br><br>The Senior Principal Scientist will lead a laboratory-focused group of cell culture and purification scientists who develop robust clinical processes to advance Amgen's biologics pipeline. As part of this opportunity, you will develop strong cross-functional teams and mentor junior staff in career development. The scope of work and responsibility span protein construct selection, clinical process development, support of technology transfer, authoring regulatory Chemistry Manufacturing Control (CMC) documents, and interacting with regulatory agencies. In addition, you will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency.<br><br><b>Key responsibilities:</b><br><ul><li>Supervise a team that provides large molecule candidate selection, robust clinical upstream and downstream processes and characterization, and enables successful global regulatory filings.</li><li>Independently author technical reports, regulatory filings, patents, peer reviewed publications, and actively participates in groundbreaking scientific conferences.</li><li>Drive technical strategies, conveys information and makes recommendations on scientific issues to senior management.</li><li>Develop technology to deliver multi-kilogram quantities of drug substance candidates in a safe, practical and efficient manner.</li><li>Provide meaningful contributions to drug substance development teams (e.g., product, process development, and product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, and project strategies.</li><li>Serve as a technical expert and keeps current in relevant literature and related technology with a track record of successful application of said technology complying to current and emerging regulatory requirements (e.g., FDA, EMA, ICH)</li><li>Work cross-functionally to author CMC regulatory documents and documentation in support of Amgen's regulatory filings.</li><li>Develop processes amenable to cGMP operation and leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity for batch and continuous processes.</li><li>Ensure that safe laboratory practices are followed.</li><li>Provides mentoring and expertise to less-experienced staff.</li><li>Achieve work in a matrix organization through others who may or may not report directly to them, internally or externally.</li><li>Motivate, develop, and coach staff while promoting team collaboration.</li></ul><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><ul><li>Doctorate in Biological Science discipline or Chemical Engineering with 6+ years of experience</li><li>Expertise and experience in mammalian cell culture, cell sciences, and protein purification</li><li>Extensive experience in development and/or support of biomanufacturing processes, including process scale-up and GMP production</li><li>Experience in CMC clinical and commercialization process development</li><li>Leadership of a lab group or leadership experience of functional or cross-functional project teams</li><li>Proven results from leadership opportunities</li><li>Track record of innovation and implementation of new technologies</li><li>Experience in authoring IND sections and interaction with regulatory agencies</li></ul><br><br>Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.<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 focuses on areas of high unmet medical need and uses 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/Do68oySmNWeYiYwysqmY6"> <p>PI117896432</p>

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Posted: 2020-02-08 Expires: 2020-03-10

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Senior Principal Scientist - Pre-Pivotal Bioprocess Development

Amgen
Thousand Oaks, CA 91360

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