Director Process Development

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director Process Development

What you will do

Lets do this! Lets change the world! This leader develops a team within Pre-Pivotal Drug Substance who are responsible for the development and advancement of a large and diverse portfolio of Biologic therapeutic molecules from Research to IND and enables GMP supply for early clinical trials. The programs represent a wide range of biologics molecules including mAbs, multi-specifics, conjugates and other novel modalities. As the primary point of contact with key leadership partners in Research, Process Development and Clinical Manufacturing you will be responsible for the delivery of data packages to support therapeutic candidate selection as well as the development and tech transfer of drug substance processes for clinical manufacturing. You will ensure the successful drug substance process development deliverables including molecule and develop ability assessments, final clone selection, upstream and downstream process development, process characterization, viral clearance and tech transfer for clinical manufacturing. In addition, you will drive implementation of new technologies, including automation, digital innovation, predictive modeling, new manufacturing technologies and process intensification. You will also ensure regulatory filings and responses to questions are managed diligently and executed with quality and rigor.

Responsibilities

• Lead diverse high performing multi-disciplinary drug substance team of 20+ staff that is comprised of an integrated cell culture and purification disciplines located in Thousand Oaks, CA.

• Develop staff and manage resource allocation for portfolio advancement and technology development

• Advance integrated holistic drug substance processes for Amgens multi-modality portfolio for pre-clinical and clinical development. This includes molecule assessment, early process development and process characterization activities, as well as supporting transfer of processes to internal and external manufacturing networks.

• Author or review IND filings and respond to global Regulatory questions.

• Champion the ideation, development, and deployment of differentiating technologies and establishing culture of innovation.

• Contribute to Amgens external eminence at scientific and regulatory conferences and other industry forums.

• Serve as member of Drug Substance Technologies (DST) extended leadership team and contribute to advancing the process development function. Work in partnership with management to develop plans that support the direction of the business, plans for implementation of transformational efforts and contributes to organizational leadership.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic leader we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 4 years of process development experience OR

• Masters degree and 8 years of process development experience OR

• Bachelors degree and 10 years of process development experience

In addition to meeting at least one of the above requirements, you must have at least 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

Preferred Qualifications:

• PhD degree in Biochemistry, Biochemical or Chemical Engineering

• 10+ years of experience in biopharmaceutical process development

• Demonstrated ability in providing scientific and engineering expertise to multi-functional teams in Process Development, Research, Manufacturing, Quality and Supply Chain to advance complex projects to completion and to interface on technical problem resolution

• Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to cross-functional audience and senior management

• Detailed understanding of all stages of drug substance process development for biologics: clinical and commercial process development, process characterization, process design, regulatory filing and responses

• Experience in authoring clinical trial and marketing authorization applications

• Strong technical communication skills, both written and verbal, to interact effectively with all team members

• Practical knowledge of the technologies related to mammalian cell culture, purification, automation, and validation

• Active participation in the scientific community through a record of peer-reviewed publications and/or patents, as well as active participation in industry forums and/or conferences

• Established success developing staff, including effective feedback and coaching or mentoring

• Exemplify 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, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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 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

• 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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

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.

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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