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.

Director Process Development

Live

What you will do

Lets do this. Lets change the world. In this vital role you will provide scientific, technical, and managerial leadership in support of late-stage drug product development. The Director of Pivotal Drug Product Technologies at the Cambridge, MA Site will also manage a team of process and formulation experts and will contribute to the strategic direction of the group, based on industry trends, future requirements, and feedback from key partners. Based on future needs, the incumbent will help direct scientific and technology investments to enhance Amgens ability to advance drug product development.

Scope of the Group:

• Commercial formulation and drug product process development
• Technology transfer to clinical manufacturing and process characterization
• Technology transfer to commercial manufacturing and marketing application authoring and response to questions
• Lifecycle management presentations for commercial products and evaluate, develop, and implement novel technology that can increase throughout and capacity and/or reducing development cycle time
• Generation, maintenance and application of platform formulations and processes as well as intellectual property considerations
• Innovation and advancement of capabilities that enables speed and efficiency in drug product development

Responsibilities of the Director Process Development include:

• Leads a high performing technical team with diverse scientific disciplines
• Effectively interfaces with partners in Process Development, Quality, Regulatory and Manufacturing to ensure optimum drug product development
• Takes a proactive role in developing and applying new approaches; demonstrates creativity in solving complex technical problems
• Provides leadership in developing strategy and experimental plan to enable drug delivery that maximizes biological efficacy, ease of administration and intended product presentation as well as oversight and direction for individuals and teams responsible for developing formulations and processes for multiple programs and therapeutic areas
• Organizes and leverage resources to maximize output while still being very innovative
• Develops and disseminate department vision and goals and connects each team members work with the bigger picture
• Provides input to the development of program strategy, budgets, timelines, and project plans. Ensures technical and business requirements are managed and met
• Deals with ambiguity and a rapidly changing environment; while easily shifting gears as needed and bring the team along
• Guides and mentor others on day-to-day performance, long term career development and through change.
• Well versed in process engineering, pharmaceutical sciences, formulation development and/or drug delivery technologies and can advocate for approaches related to drug administration
• Regularly interacts with senior management and executives to create broad-based departmental direction
• Contributes to regulatory filings including INDs, CTAs and MAs; as needed assists in answering questions from regulatory authorities.
• Rigorously reviews of all department scientific and regulatory deliverables
• Effectively manages a cross-site (Cambridge, MA and Thousand Oaks, CA) department

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Director Level professional we seek is a leader 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
AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• A Doctorate 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 his/her interactions: excels at problem solving, asking the tough questions, and can take the heat and make difficult decisions
• Strong focus on influencing, coaching, motivating, and providing career and scientific/technical advice to staff
• Strong networking skills to work across organizations to advance innovated processes, approaches, and methodologies
• Executes with a sense of purpose and drives course corrections where appropriate
• Excellent written, verbal, communication, and presentation skills - ability to distill, craft and present key messages relative to diverse audience requirements
• Established knowledge of applicable global regulatory requirements and experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters

Thrive

What you can expect of us

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

The annual salary range for this opportunity in the U.S. is $190,961 - $216,256.

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

Apply Now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.