Director Process Development - Drug Substance

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Director Process Development - Drug Substance
What you will do

Let's do this. Let's change the world! In this vital role, you will be responsible for scientific and technical leadership of Cell Sciences & Engineering (CSE) function reporting to the Executive Director of the Drug Substance Process Development group at Amgen's Puerto Rico site. Oversight responsibilities span commercialization through full scale process validation and lifecycle management of processes in support of drug substance manufacturing operations. This leader will work in close collaboration with Manufacturing, Engineering, and Quality functions to enable progressive improvements in drug substance manufacturing processes. This role will direct strategic responsibility for leading a team of 20+ scientists/engineers to support a growing portfolio.

Specific responsibilities include but are not limited to:

• Cell culture process technology transfer to and from the site
• Process validation at scale across the two drug substance manufacturing plants
• Drug substance CMC authoring activities for products
• Process monitoring activities (real time multi-variate statistical process monitoring)
• Life cycle improvements in commercial cell culture processes
• Assure manufacturing operations are aligned with the registered process
• Responsible for oversight of the Data Sciences and Analytics for the unit
• 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Director Process Development professional we seek is a collaborative leader with these qualifications.
Basic Qualifications:

Doctorate degree and 4 years of Scientific experience

OR

Master's degree and 8 years of Scientific experience

OR

Bachelor's degree and 10 years of Scientific experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Beyond that, additional preferred qualifications are:

• PhD with 10+ years technical experience or a MS with 15+ years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline and 5+ years of managerial experience in a cGMP environment.
• Practical knowledge of the technologies related to mammalian and microbial cell culture, 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.
• 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.
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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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

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