Principal Scientist, PREPIVOTAL DRUG PRODUCT TECHNOLOGIES
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 expertise to forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Principal Scientist, PREPIVOTAL DRUG PRODUCT TECHNOLOGIES
What you will do
In this role you will join Amgens Pre-Pivotal Drug Product technologies organization reporting to the Director of Synthetics Enabling Technologies, a developability/molecule assessment organization. You will lead a team of scientists and associates, and, contribute to the strategic direction of the group based on industry trends, future requirements and feedback from key partners. Specifically, the successful candidate will:
- Provide scientific, technical and managerial leadership to enable preclinical formulation development, lead optimization and form selection of therapeutic candidates to meet Target Product Profiles and preferred product presentations for synthetics programs.
- Conduct biopharmaceutical assessments utilizing predictive in silico and in vitro models to support molecule assessment, form selection, and formulation development, identifying development strategies.
- Support early clinical development for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and technical transfers to support clinical manufacturing (GMP).
- Contribute to regulatory filings including IND and NDA and assists in answering questions from regulatory authorities as needed.
- Guide and mentor others on day to day performance, long term career development and through change.
- Build and maintain strong working relationships with relevant internal and external customers and partners.
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is an innovator with these qualifications.
- Doctorate degree & 3 years of scientific experience OR
- Masters degree & 6 years of scientific experience OR
- Bachelors degree & 8 years of scientific experience
- Doctorate Degree with 8+ years in one of the following areas: Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Organic Chemistry, Physical Chemistry, Biochemistry, Protein Chemistry, or a related field.
- 8+ years of formulation, preformulation, and developability assessment experience with successful track record (including peer-review journal publications).
- Experience utilizing computational predictive tools for biopharmaceutical assessments (GastroPlus, or related programs)
- Experience in solid state characterization and/or material sciences utilizing predictive in silico tools (i.e. Mercury, Materials Studio, or related programs) is a plus.
- Established knowledge of applicable global regulatory requirements including preparation of technical sections.
- Knowledge of automated screening platforms and strategies is highly beneficial.
- Strong focus on mentoring, motivating and providing career and scientific/technical advice to staff.
- Demonstrable track record of taking initiative and implementing innovative approaches and ideas.
- Ability to think strategically to align and identify needs with incoming portfolio opportunities.
- Flexibility to be able to work in a cross-functional, multi-disciplinary environment.
- Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, interdisciplinary team-based environment.
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.
- Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
- 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
- Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
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 focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
If youre 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, youll 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.
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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.