21 days old

Director of Drug Substance Technologies - Pivotal & Commercial Synthetics - Synthetic Chemistry

Amgen
Cambridge, MA 02138
  • Job Code
    117524336
  • Jobs Rated
    70th
Amgen

Job ID: R-91665
Location: Cambridge, MA, US 02139

Amgen is seeking a Director, Drug Substance Technologies-Pivotal & Commercial Synthetics-Synthetic Chemistry who will be responsible for leading a team and program who will drive synthetic chemistry, drug substance commercial process development, technology transfer and commercial support for Amgen's small molecule pipeline. This position will be integral in leading key activities including: route selection, process design, process characterization, site selection and technology transfer. The Director, Drug Substance Technologies will be based out of Amgen's 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 will include the following:

• Accountable for leading the managing the team and ensuring that the Pivotal & Commercial Synthetics vision, mission, charter and strategy are implemented and upheld
• Responsible for aligning department with Amgen's overall mission and values
• Ensures that performance and career development are effectively managed within the group
• Establishes and maintains cross-functional partnerships (e.g. PrePivotal Drug Substance Technologies, Drug Product Technologies, Attribute Sciences, Manufacturing, Quality and Regulatory)
• Designates project representative responsibilities as appropriate
• 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 chemistry related to drug substance development and manufacture
• Provide support to group Leaders for regulatory submissions, investigations, and product development
• Extensive knowledge of GLP (Good Lab Practices) and (Good Manufacturing Practices) GMP activities for scale-up and manufacture of Amgen's drug substance candidates
• Understands the technical and/or scientific capabilities of the department and provides guidance to senior staff members to resolve scientific/technical issues
• Provides critical evaluation of engineering data for drug substance provided by senior staff in support of regulatory submissions, investigations, and product development
• Clearly understands and applies knowledge of regulatory requirements (FDA, ICH, USP, etc.) to completion of projects
• 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
• Ensures staff are qualified by education, training and/or experience to perform their respective tasks
• 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

• Contributes to the overall operation of the department including resource and budget planning
• Initiates and encourages scientific collaboration with groups outside the department

• Anticipates, proactively detects, and addresses problems related to departmental and interdepartmental activities.
• Informs and consults management and senior staff appropriately

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


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


Preferred Qualifications:
  • 10+ 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
  • Demonstrated ability to apply creative thinking to problem solving and research
  • Strong problem-solving skills, including application of scientific theory
  • Strong background in synthetic organic chemistry-up to date knowledge of modern synthesis and catalysis methods
  • Knowledge of chemical process development of API, process characterization and validation
  • Knowledge of GLP, clinical and commercial manufacturing GMP
  • Strong experience with regulatory requirements for API/Product (CMC for IND/NDA, GLP/GMP, ICH)
  • Strong experience with technology transfers


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.

PI117524336

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91665<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is seeking a Director, Drug Substance Technologies-Pivotal & Commercial Synthetics-Synthetic Chemistry who will be responsible for leading a team and program who will drive synthetic chemistry, drug substance commercial process development, technology transfer and commercial support for Amgen's small molecule pipeline. This position will be integral in leading key activities including: route selection, process design, process characterization, site selection and technology transfer. The Director, Drug Substance Technologies will be based out of Amgen's 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 will include the following:<br><br> Accountable for leading the managing the team and ensuring that the Pivotal & Commercial Synthetics vision, mission, charter and strategy are implemented and upheld<br> Responsible for aligning department with Amgen's overall mission and values<br> Ensures that performance and career development are effectively managed within the group<br> Establishes and maintains cross-functional partnerships (e.g. PrePivotal Drug Substance Technologies, Drug Product Technologies, Attribute Sciences, Manufacturing, Quality and Regulatory)<br> Designates project representative responsibilities as appropriate<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 chemistry related to drug substance development and manufacture<br> Provide support to group Leaders for regulatory submissions, investigations, and product development<br> Extensive knowledge of GLP (Good Lab Practices) and (Good Manufacturing Practices) GMP activities for scale-up and manufacture of Amgen's drug substance candidates<br> Understands the technical and/or scientific capabilities of the department and provides guidance to senior staff members to resolve scientific/technical issues<br> Provides critical evaluation of engineering data for drug substance provided by senior staff in support of regulatory submissions, investigations, and product development<br> Clearly understands and applies knowledge of regulatory requirements (FDA, ICH, USP, etc.) to completion of projects<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> Ensures staff are qualified by education, training and/or experience to perform their respective tasks<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> 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> Anticipates, proactively detects, and addresses problems related to departmental and interdepartmental activities.<br> Informs and consults management and senior staff appropriately<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><ul><li>Master's degree and 8 years of Process Development, Engineering or Manufacturing experience</li></ul><br><br>OR<br><ul><li>Bachelor's degree and 10 years of Process Development, Engineering or Manufacturing experience</li></ul><br><br><ul><li>4 years of 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><ul><li>10+ 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>Demonstrated ability to apply creative thinking to problem solving and research</li><li>Strong problem-solving skills, including application of scientific theory</li><li>Strong background in synthetic organic chemistry-up to date knowledge of modern synthesis and catalysis methods</li><li>Knowledge of chemical process development of API, process characterization and validation</li><li>Knowledge of GLP, clinical and commercial manufacturing GMP</li><li>Strong experience with regulatory requirements for API/Product (CMC for IND/NDA, GLP/GMP, ICH)</li><li>Strong experience with technology transfers</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/LYgnXoi1xN1NuB74iq27g"> <p>PI117524336</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 - Synthetic Chemistry

Amgen
Cambridge, MA 02138

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