Process Development Director
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. Join us.
What you will do
Lets do this. Lets change the world. In this dynamic role you will be contributing to advancing scientific knowledge as well as contributing to the advancement of clinical candidates. Working in a science-based organization, the successful scientist will drive continuous improvement in our knowledge of protein behavior through technological innovation and application of findings and actively contribute to the evolution of our understanding of the drivers of aggregation and surface interactions. The findings will build opportunities to influence the development of new and existing therapeutic biological modalities. Cross-functional collaborations are encouraged. Experience in designing and implementing new technologies is required. This is a phenomenal opportunity for a highly motivated and creative candidate to develop, advance and apply protein biochemistry/polymer technologies to drug delivery challenges. Responsibilities include:
- Lead a talented team responsible for First-in-Human drug product development for biologics portfolio
- Influence molecule selection and advancement of therapeutic candidates that can meet the Target Product Profile and preferred product presentation
- Handle a large portfolio by providing input to drive the development of program strategies, timelines and project plans
- Provide leadership to project teams developing strategies and experimental plans to enable drug delivery that maximizes biological efficacy, ease of administration and intended product presentation
- Establish and maintain partnership agreements with counterparts across R&D and Operations, including across Process Development, Quality, Regulatory, Clinical Supply and Manufacturing
- Provide creative strategies to improve team engagement and ensure team reaches full potential
- Display technical acuity in process engineering, pharmaceutical sciences, formulation development and/or drug delivery technologies, applying innovative ways, and demonstrating creativity in solving problems
- Drive alignment of drug product development standard methodologies and initiatives
- Apply data science to build prior knowledge summaries that drive study designs
- Identify and implement innovative solutions and technologies to resolve sophisticated problems and drive continuous improvement
- Provide oversight and leadership of innovation in molecule/protein engineering, high throughput/automation, optimizing patient experience, and novel drug delivery technologies
- Ensure technical and business requirements are met on time
- Deftly handle ambiguity and a dynamic environment by showing the ability to easily shift gears and bring the team along
- Dedication to compliance and safety
- Display an acute awareness of industry and literature trends
- Regularly work with senior management and executives to create broad-based departmental direction
- Develop and roll out department vision and goals and connect each team members work with the bigger picture
- Critically review of all department scientific and regulatory documents (including questions from regulatory authorities)
- Advance Amgens high throughput screening capabilities
- Balance resources, prioritize, promote fungible resourcing
- Manage budgets, including capital, staff travel and staff training
- Guide and mentor staff day-to-day performance, long term career development and through change
- Display a strong, unwavering dedication to Diversity, Inclusion, and Belonging
- Effectively manage staff (leading by example) through return to work phase
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Biomedical/Pharma Scientific professional we seek is a collaborative partner 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 AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- 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 subject area
- 14+ years of pharmaceutical development and 10+ years of management experience
- 12+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization.
- Demonstrated knowledge of drug product stability assessments and mitigation strategies
- Demonstrates courage in all of his/her interactions: excels at asking the tough questions, can take the heat and make difficult decisions
- Strong focus on 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, 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.
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.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
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.
#PD2021Equal Opportunity Statement
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 a 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 an accommodation.
Join UsIf 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 cancer, 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.