21 days old

Director of Drug Substance Technologies - Pivotal & Commercial Synthetics - Process Engineering

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117524317
Amgen

Job ID: R-91667
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Massachusetts - Cambridge

The Director, Drug Substance Technologies-Pivotal & Commercial Synthetics-Process Engineering will be responsible for leading a group accountable for all process engineering aspects supporting drug substance commercial process development, technology transfer and commercial support for Amgen's small molecule pipeline. This position will drive key activities include: process design and modelling, unit operation design, site selection and technology transfer. The Director, Drug Substance Technologies will be based out of Amgen's Thousand Oaks, California or Cambridge, Massachusetts facility and will report to the Executive Director of Process Development.

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 include:

• Accountable for ensuring that the Pivotal & Commercial Synthetics vision, mission, charter and strategy are implemented and upheld

• Responsible for leading the department with Amgen's overall mission and values
• Manages and drives the performance and career development within the team of process engineers

• Establishes and maintains cross-functional partnerships (e.g. PrePivotal Drug Substance Technologies, Drug Product Technologies, Attribute Sciences, Manufacturing, Quality and Regulatory)
• Directly responsible for company-wide and department level activities (e.g. budgeting, capital allocation, project assignment, alignment initiatives, setting vision/direction/strategy and technology development)
• Reviews and approves the departmental technical and regulatory documents
• Participates in or organizes departmental committees to address departmental and interdepartmental problem solving, and activities.
• Ensures that industry standards and best practices that fits Amgen's business needs are effectively applied
• Stays abreast of issues that may impact Pivotal & Commercial Synthetics business
• Represents Pivotal & Commercial Synthetics as a scientific, regulatory and technical expert
• Serves as a technical expert and keeps current in process engineering related to drug substance development and manufacture
• Provide support to Group Leaders for regulatory submissions, investigations, and product development
• Extensive knowledge of Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMP) activities for scale-up and manufacture of Amgen's drug substance candidates
• Conveys a broader level of understanding in pharmaceutical R&D and commercialization to the department
• Provides critical evaluation of engineering data for drug substance provided by senior staff in support of regulatory submissions, investigations, and product development
• Leads and/or participates in technical forums for sharing of best practices and application of scientific expertise
• Has clear understanding of digital tools to facilitate workflows
• Strives for adequate utilization of automation during process development

• Routinely leads and contributes to critical drug substance development teams by providing leadership in scientific, technical and regulatory issues
• Negotiates for resources identified by the group leaders and establishes priority for projected activities.
• Oversees the execution of unit operations for the scale-up for development, manufacture and release of our clinical and commercial drug substances under both GLP and GMP

• Provides adequate feedback through coaching and effective performance appraisal and development planning
• Contributes to the overall operation of the department including resource and budget planning
• Initiates and encourages scientific collaboration with groups outside the department

Basic Qualifications:

  • Doctorate degree and 4 years of Process Development, Engineering or Manufacturing experience


OR

  • Master's degree and 8 years of Process Development, Engineering or Manufacturing experience


OR

  • Bachelor's degree and 10 years of Process Development, Engineering or Manufacturing experience


AND

  • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources


Preferred Qualifications:

  • MS or Ph.D. in Chemical Engineering
  • 12+ years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams, and successful leadership of drug substance project groups
  • Excellent written and oral communication skills
  • Strong mindset for digitization and modeling tools


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.

PI117524317

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91667<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Massachusetts - Cambridge<br/><br/>The Director, Drug Substance Technologies-Pivotal & Commercial Synthetics-Process Engineering will be responsible for leading a group accountable for all process engineering aspects supporting drug substance commercial process development, technology transfer and commercial support for Amgen's small molecule pipeline. This position will drive key activities include: process design and modelling, unit operation design, site selection and technology transfer. The Director, Drug Substance Technologies will be based out of Amgen's Thousand Oaks, California or Cambridge, Massachusetts facility and will report to the Executive Director of Process Development.<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 include: <br><br> Accountable for ensuring that the Pivotal & Commercial Synthetics vision, mission, charter and strategy are implemented and upheld<br><br> Responsible for leading the department with Amgen's overall mission and values<br> Manages and drives the performance and career development within the team of process engineers<br><br> Establishes and maintains cross-functional partnerships (e.g. PrePivotal Drug Substance Technologies, Drug Product Technologies, Attribute Sciences, Manufacturing, Quality and Regulatory)<br> Directly responsible for company-wide and department level activities (e.g. budgeting, capital allocation, project assignment, alignment initiatives, setting vision/direction/strategy and technology development)<br> Reviews and approves the departmental technical and regulatory documents<br> Participates in or organizes departmental committees to address departmental and interdepartmental problem solving, and activities.<br> Ensures that industry standards and best practices that fits Amgen's business needs are effectively applied<br> Stays abreast of issues that may impact Pivotal & Commercial Synthetics business<br> Represents Pivotal & Commercial Synthetics as a scientific, regulatory and technical expert<br> Serves as a technical expert and keeps current in process engineering related to drug substance development and manufacture<br> Provide support to Group Leaders for regulatory submissions, investigations, and product development<br> Extensive knowledge of Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMP) activities for scale-up and manufacture of Amgen's drug substance candidates<br> Conveys a broader level of understanding in pharmaceutical R&D and commercialization to the department<br> Provides critical evaluation of engineering data for drug substance provided by senior staff in support of regulatory submissions, investigations, and product development<br> Leads and/or participates in technical forums for sharing of best practices and application of scientific expertise<br> Has clear understanding of digital tools to facilitate workflows<br> Strives for adequate utilization of automation during process development<br><br> Routinely leads and contributes to critical drug substance development teams by providing leadership in scientific, technical and regulatory issues<br> Negotiates for resources identified by the group leaders and establishes priority for projected activities.<br> Oversees the execution of unit operations for the scale-up for development, manufacture and release of our clinical and commercial drug substances under both GLP and GMP<br><br> Provides adequate feedback through coaching and effective performance appraisal and development planning<br> Contributes to the overall operation of the department including resource and budget planning<br> Initiates and encourages scientific collaboration with groups outside the department<br><br>Basic Qualifications:<br><br><ul><li>Doctorate degree and 4 years of Process Development, Engineering or Manufacturing experience</li></ul><br><br>OR<br><br><ul><li>Master's degree and 8 years of Process Development, Engineering or Manufacturing experience</li></ul><br><br>OR<br><br><ul><li>Bachelor's degree and 10 years of Process Development, Engineering or Manufacturing experience</li></ul><br><br>AND<br><br><ul><li>4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources</li></ul><br><br>Preferred Qualifications:<br><br><ul><li>MS or Ph.D. in Chemical Engineering</li><li>12+ years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams, and successful leadership of drug substance project groups</li><li>Excellent written and oral communication skills</li><li>Strong mindset for digitization and modeling tools</li></ul><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/b7ObwnhPDjPBixEkINmMp"> <p>PI117524317</p>

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Posted: 2020-01-28 Expires: 2020-02-28

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Director of Drug Substance Technologies - Pivotal & Commercial Synthetics - Process Engineering

Amgen
Thousand Oaks, CA 91360

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