Executive Director, Process Development

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Process Development

Live

What you will do

Lets do this. Lets change the world. In this vital role as Executive Director, Process Development you will be a part of Process Development, Drug Substance Technologies Synthetics (DSTS) and play an important role in developing and delivering robust drug substance manufacturing processes and technologies to serve patients.

DSTS is an integrated end-to-end organization that is accountable to Invent, develop, and implement drug substance manufacturing processes and technologies to advance and sustain Amgens synthetics and hybrids portfolio.

This team operates as a matrixed organization relying on integration, centers of expertise and fungibility of resources to maintain and continuously improve process development contributions to our synthetic portfolio.

The Executive Director of DSTS is responsible for leading the synthetics team and serving as the primary department representative for Synthetics Drug Substance Technologies on departmental and interdepartmental work to advance and commercialize the synthetic portfolio, inclusive of hybrid modalities (peptides, oligonucleotides and bioconjugates). This role reports into Vice President, Drug Substance Technologies.

Responsibilities

Accountable for developing and ensuring that the DSTS vision, mission, and strategy are implemented and upheld

Accountable to rapidly advance a diverse synthetics portfolio of molecules (including small molecules, bioconjugates, ADCs, peptides, oligonucleotides), from research through to commercialization working with our Partners across Operations and our internal and external manufacturing network

Back-integrates into R&D, to provide advice on the Target Product Profile, Synthetic Process Challenges and Final Form to advance the candidates into the clinic.

Forward-integrates into the commercial network and partner with the Amgen Contract Development and Manufacturing (ACDM) organization to Tech Transfer our synthetic processes in the external Manufacturing Network and inform them of potential issues to set them up for success in commercialization efforts

Establish and maintain partnership agreements with peer organizations, e.g. ACDM, Attribute Sciences (AS), Drug Product Technologies (DPT), Quality, Regulatory, Clinical Supply and Commercial Manufacturing (internal and external)

Represent Drug Substance Technologies as a scientific, regulatory and technical expert both internally and externally

Designate project representative responsibilities as appropriate

Manage company-wide and department level activities (e.g. budgeting, capital allocation, project assignment, alignment initiatives, setting vision / direction / strategy and technology development)

Participates in, or organizes, departmental committees to address departmental and interdepartmental initiatives

Ensures that staff performance and career development are managed and succession plans are active and advanced

Ensure that industry standards and best practices that fit Amgens business needs are effectively applied

Stays abreast of issues that may impact the DSTS business

Evaluate, resolve and / or escalate issues in a timely manner

Responsible for developing next-generation leaders from within the function and building strong succession plans across all levels in DSTS

SCIENTIFIC / TECHNICAL

Serves as a technical expert and keeps current in drug substance development, including literature and technology development for cutting edge and regulatory driven activities

Provide support to Drug Substance Team Leaders for regulatory submissions, investigations, and product development (supporting ACDM, DPT, AS, Quality, Regulatory and clinical supply)

Extensive knowledge of GLP and GMP activities

Understands the technical and / or scientific capabilities of the department and provides guidance to senior staff members to resolve scientific / technical issues

Conveys a broader level of understanding in pharmaceutical R&D and commercialization

Familiar with the drug development process and requirements of regulatory submissions

Clearly understands and applies knowledge of regulatory requirements (FDA, ICH, USP, etc.) to completion of projects

Oversees and upholds proper safety practices

Leads and / or participates in technical forums for sharing of best practices and application of scientific expertise

MENTORSHIP

Ensures that safe laboratory practices are followed

Ensures staff are qualified by education, training and / or experience to perform their respective tasks

Provides mentoring and expertise to less-experienced staff

Motivates others who may or may not report directly to them

Motivates, develops, and coaches staff while promoting team collaboration

Applies effective management practices in the direction and development of others

Oversees the execution of drug substance development, scale-up and manufacture to support clinical and commercial synthetic candidates

LEADERSHIP & INFLUENCE

Provides clear and consistent vision and direction

Is the SME for DST and represents their function across Operations and our interfaces

Identifies and negotiates resources and develops timelines for project activities.

Negotiates and collaborates inter departmentally

Provides scientific and technical leadership

Ensures department staff are adequately trained

Provides feedback through coaching and effective performance appraisal and development planning

Contributes to the overall operation of the department including resource and budget planning

Initiates and encourages scientific collaboration with groups outside the department

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.

Basic Qualifications :

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

Masters 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

MS with 20 years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry

Appropriate technical discipline and 12 years of managerial experience in a cGMP environment and

Practical knowledge of the technologies related to analytical technologies, mammalian and microbial cell culture, protein purification, automation, validation and process engineering

Experience in authoring marketing authorization applications

Known within the scientific community through a record of peer-reviewed publications and / or patents

They will also embody the Amgen leadership attributes which are :

Inspire : Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

Accelerate : Enable speed that matches the urgency of patient needs by encouraging progress over perfection

Integrate : Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

Adapt : Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

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 towards retirement or other goals, work / life balance, and career development opportunities including :

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

Amgens Commitment to Our Staff

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our people-first philosophy.

We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

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 an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

Salary : $268,622 - $321,865