Director Process Development - Pivotal Biologics, Drug Product Technologies

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Director Process Development: Pivotal Biologics - Drug Product Technologies

What you will do

Lets do this. Lets change the world. In this vital role as a Director within the Pivotal Biologics group in Drug Product Technologies, you will provide scientific, technical, and managerial leadership in support of late-stage biologic drug product development. The role, based at the Thousand Oaks, CA site, will manage a team of process and formulation experts in the simultaneous development of multiple products within Amgens portfolio, relying on your technical and scientific expertise to overcome development challenges and optimize both process and product. You will be a member of the Pivotal Biologics leadership team and contribute to the strategic direction of the group, responding to industry trends, future business requirements, and inputs from key partners.

• Development of commercial formulations and drug product processes for products that span Amgens biologics pipeline, including new constructs, biosimilars, and lifecycle management opportunities within the commercial portfolio.
• Technology transfer to clinical manufacturing and process characterization.
• Technology transfer to commercial manufacturing and authoring of the marketing application and responses to agency questions.
• Advancement of novel technology and capabilities that can increase throughput and capacity and/or reduce development cycle time.
• Generation, maintenance, and application of efficiency enabling formulation and process platforms.

• Lead a high-performing technical team, fostering diversity in scientific and engineering skills.
• Interface seamlessly with partners in Process Development, Quality, Regulatory, and Manufacturing to optimize drug product development.
• Provide visionary leadership in devising strategies and experimental plans for drug delivery, emphasizing biological efficacy, ease of administration, and enabling target product presentations. Offer oversight and direction to teams handling formulations and processes across multiple programs and therapeutic areas.
• Efficiently organize and leverage resources for maximum output while fostering innovation.
• Develop and communicate a compelling department vision, aligning each team member's work with the broader organizational goals.
• Provide input on program strategy, budgets, timelines, and project plans. Ensure the management and fulfillment of technical and business requirements.
• Navigate ambiguity and rapid changes adeptly, smoothly transitioning and rallying the team when needed.
• Guide and mentor team members in day-to-day performance, long-term career development, and during times of change.
• Possess expertise in process engineering, pharmaceutical sciences, formulation development, and drug delivery technologies.
• Regularly engage with senior management and executives, shaping comprehensive departmental direction.
• Contribute to regulatory filings, including INDs, CTAs, and MAs; assist in addressing regulatory authorities' inquiries as needed.
• Rigorously review all scientific and regulatory deliverables.
• Demonstrate flexibility for domestic and international travel, up to 10% of the time.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Process Development professional we seek is a leader with these 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 a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

• Doctorate degree in one of the following areas: Biology, Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering, or a related scientific discipline.
• 10+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization.
• 10+ years of management experience.
• Demonstrated knowledge of drug stability assessment and mitigation strategies.
• Demonstrates people-centered leadership in all of interactions: excels at problem solving, asks tough questions, makes difficult decisions, and can strongly defend a position but also be responsive to feedback.
• Strong focus on mentoring, coaching, motivating, and providing career and scientific/technical advice to staff.
• Strong networking skills to work across organizations to advance innovative processes, approaches, and methodologies.
• Executes with a sense of purpose; drives course corrections where appropriate.
• Excellent written, verbal, communication, and presentation skills. Demonstrates the ability to distill, craft, and present key messages relative to diverse audience requirements, accurately identifying the correct strategic altitude and communication style.
• Established knowledge of applicable global regulatory requirements and experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters.

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.

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.