Amgen
Executive Director, Process Development
– Amgen
Our Mission At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—you help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Executive Director, Drug Substance Process Development In this vital role, you are 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 for Amgen’s mammalian and microbial DS manufacturing facilities in Puerto Rico. This executive leader will work in close collaboration with Manufacturing, Engineering, Finance, Supply Chain and Quality functions to enable progressive improvements in commercial processes and analytical methods. You will have direct strategic responsibility for leading a team of 80+ scientists/engineers to support a growing portfolio with increased volumes. 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.
Responsibilities
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, the latter in partnership with Attribute Sciences
Process monitoring activities, including real‑time multi‑variate statistical process monitoring
Life‑cycle improvements in commercial process, including improvements to increase yields and reduce cost of manufactured
Ensure manufacturing operations are aligned with the registered process
Provide oversight and support for technical investigations
Safety and compliance of process development activities
Developing strategy, setting goals and priorities, allocating resources, monitoring project progress, and managing the organization’s budget
Qualifications Basic Qualifications
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 ORli>
Bachelor’s degree and 12 years of Scientific, Process Development and/or Technical Service experience
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 an 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
Business acumen with track record of innovation and continuous improvement that provided strong financial benefits
Benefits The annual base salary range for this opportunity in the U.S. is $268,622 - $321,865. In addition to the base salary, Amgen offers a Total Rewards Plan, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work/life balance, and career development opportunities.
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
Stock‑based long‑term incentives
Award‑winning time‑off plans and bi‑annual company‑wide shutdowns
Flexible work models, including remote work arrangements, where possible
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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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– Amgen
Our Mission At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—you help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Executive Director, Drug Substance Process Development In this vital role, you are 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 for Amgen’s mammalian and microbial DS manufacturing facilities in Puerto Rico. This executive leader will work in close collaboration with Manufacturing, Engineering, Finance, Supply Chain and Quality functions to enable progressive improvements in commercial processes and analytical methods. You will have direct strategic responsibility for leading a team of 80+ scientists/engineers to support a growing portfolio with increased volumes. 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.
Responsibilities
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, the latter in partnership with Attribute Sciences
Process monitoring activities, including real‑time multi‑variate statistical process monitoring
Life‑cycle improvements in commercial process, including improvements to increase yields and reduce cost of manufactured
Ensure manufacturing operations are aligned with the registered process
Provide oversight and support for technical investigations
Safety and compliance of process development activities
Developing strategy, setting goals and priorities, allocating resources, monitoring project progress, and managing the organization’s budget
Qualifications Basic Qualifications
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 ORli>
Bachelor’s degree and 12 years of Scientific, Process Development and/or Technical Service experience
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 an 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
Business acumen with track record of innovation and continuous improvement that provided strong financial benefits
Benefits The annual base salary range for this opportunity in the U.S. is $268,622 - $321,865. In addition to the base salary, Amgen offers a Total Rewards Plan, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work/life balance, and career development opportunities.
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
Stock‑based long‑term incentives
Award‑winning time‑off plans and bi‑annual company‑wide shutdowns
Flexible work models, including remote work arrangements, where possible
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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
#J-18808-Ljbffr