1+ months

Executive Director Process Development - Drug Substance

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    116491574
Amgen

Job ID: R-90382
Location: Juncos, PR, US 00777

The role

The Executive Director, Drug Substance Process Development is responsible for scientific and technical leadership of Drug Substance (DS) manufacturing processes and Attribute Sciences functions at Amgen's Puerto Rico site. Oversight responsibilities span commercialization through full scale process validation and life-cycle management of processes and methods supported by Amgen's Puerto Rico operations. This leader will work in close collaboration with Manufacturing, Engineering, and Quality functions to enable progressive improvements in commercial processes and analytical methods. He/she will have direct strategic responsibility for leading a team of 70+ scientists/engineers to support a growing portfolio. This position reports to the Vice President of Drug Substance Manufacturing, Amgen Manufacturing Limited (AML) and has a dotted line reporting to Vice President of Drug Substance Technologies, Process development.

Specific responsibilities include but are not limited to :

  • Drug substance technology and analytical method transfer to and from the site
  • Process validation at scale across the two DS manufacturing plants
  • Drug substance and Attribute science CMC authoring activities for products
  • Process monitoring activities (real time multi-variate statistical process monitoring)
  • Life cycle improvements in commercial process
  • Assure manufacturing operations are aligned with the registered process
  • Provide oversight and support for technical investigations
  • Safety and compliance of process development activities
  • Setting goals and priorities, allocating resources, monitoring project progress, and managing the organization's budget


Basic Qualifications - Education / Experience

Doctorate degree and 6 years of Scientific, Process Development and/or Technical Service experience

OR

Master's degree and 10 years of Scientific, Process Development and/or Technical Service experience

OR

Bachelor's degree and 12 years of Scientific, Process Development and/or Technical Service experience

And

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

Preferred Qualifications

  • PhD with 15+ years technical experience or a MS with 20+ years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline and 10+ years of managerial experience in a cGMP environment.
  • Practical knowledge of the technologies related to analytical technologies, mammalian and microbial cell culture, protein purification, automation, validation and process engineering
  • Strong technical communication skills, both written and verbal, to interact effectively with all stakeholders
  • Experience in authoring marketing authorization applications
  • Well-recognized in the scientific community through a record of peer-reviewed publications and/or patents
  • Demonstrated success developing staff, including effective feedback and coaching
  • Demonstrated collaborative experience and ability to effectively work through others


The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

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 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.

PI116491574

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90382<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/><b>The role</b><br><br>The Executive Director, Drug Substance Process Development is responsible for scientific and technical leadership of Drug Substance (DS) manufacturing processes and Attribute Sciences functions at Amgen's Puerto Rico site. Oversight responsibilities span commercialization through full scale process validation and life-cycle management of processes and methods supported by Amgen's Puerto Rico operations. This leader will work in close collaboration with Manufacturing, Engineering, and Quality functions to enable progressive improvements in commercial processes and analytical methods. He/she will have direct strategic responsibility for leading a team of 70+ scientists/engineers to support a growing portfolio. This position reports to the Vice President of Drug Substance Manufacturing, Amgen Manufacturing Limited (AML) and has a dotted line reporting to Vice President of Drug Substance Technologies, Process development.<br><br><b>Specific responsibilities include but are not limited to :</b><br><br><ul><li>Drug substance technology and analytical method transfer to and from the site</li><li>Process validation at scale across the two DS manufacturing plants</li><li>Drug substance and Attribute science CMC authoring activities for products</li><li>Process monitoring activities (real time multi-variate statistical process monitoring)</li><li>Life cycle improvements in commercial process</li><li>Assure manufacturing operations are aligned with the registered process</li><li>Provide oversight and support for technical investigations</li><li>Safety and compliance of process development activities</li><li>Setting goals and priorities, allocating resources, monitoring project progress, and managing the organization's budget</li></ul><br><br><b>Basic Qualifications - Education / Experience</b><br><br>Doctorate degree and 6 years of Scientific, Process Development and/or Technical Service experience<br><br>OR<br><br>Master's degree and 10 years of Scientific, Process Development and/or Technical Service experience<br><br>OR<br><br>Bachelor's degree and 12 years of Scientific, Process Development and/or Technical Service experience<br><br>And<br><br>6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources<br><br><b>Preferred Qualifications</b><br><br><ul><li>PhD with 15+ years technical experience or a MS with 20+ years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline and 10+ years of managerial experience in a cGMP environment.</li><li>Practical knowledge of the technologies related to analytical technologies, mammalian and microbial cell culture, protein purification, automation, validation and process engineering</li><li>Strong technical communication skills, both written and verbal, to interact effectively with all stakeholders</li><li>Experience in authoring marketing authorization applications</li><li>Well-recognized in the scientific community through a record of peer-reviewed publications and/or patents</li><li>Demonstrated success developing staff, including effective feedback and coaching</li><li>Demonstrated collaborative experience and ability to effectively work through others</li></ul><br><br><b>The benefits</b><br><br>Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.<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 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/wyz4xesnqRyEsJVoiqDdG"> <p>PI116491574</p>

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Posted: 2019-12-20 Expires: 2020-01-20

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Executive Director Process Development - Drug Substance

Amgen
Juncos, Puerto Rico 00777

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