Process Development Principal Engineer (Drug Product)
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.
Process Development Principal Engineer (Drug Product)Live
What you will do
Lets do this. Lets change the world. In this vital role you will be a part of our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group develops the drug product formulation and fill/finish process for late-stage biologics. The Principal Engineer will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.Responsibilities include:
- Lead integrated drug product teams responsible for formulation development, fill/finish process development/characterization, technology transfer, and regulatory authoring for pipeline and lifecycle management projects.
- Participate in and lead functionally diverse teams working effectively in a highly matrixed environment to inspire change, efficiency, and strong relationships through technical initiatives.
- Coordinate and participate in the planning, design, completion, and documentation of formulation and fill/finish process development studies.
- Lead and develop a team of engineers and scientists to advance program and functional objectives.
- Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections to enable IND and marketing application submissions.
- Propel continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
- Act as an authority in drug product technologies, advancing our capabilities and establishing standard approaches to improve efficiency.
- Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
- Expand the use of sophisticated IS systems to improve drug product design through faster data assessment, application of historical information, and statistical analysis of large data sets.
- Ability to travel domestically and internationally 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 biopharma scientific professional we seek is a collaborative and innovative with these qualifications.Basic Qualifications
Doctorate degree & 2 years of Engineering and/or Operations experienceOr
Masters degree & 6 years of Engineering and/or Operations experienceOr
Bachelors degree & 8 years of Engineering and/or Operations experienceOr
Associates degree and 10 years of Engineering and/or Operations experienceOr
High school diploma / GED and 12 years of Engineering and/or Operations experiencePreferred Qualifications
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline
- 5+ years of working experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring
- Leadership of highly technical specialists with demonstrated results driving forward pipeline and lifecycle management programs to bring new biotech products to market, across various dosage forms and device delivery systems.
- Hands-on experience bringing new biotech products to market, across various dosage forms and device delivery systems.
- Outstanding knowledge of aseptic processing and visual inspection of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings.
- Strong problem solving and effective interpersonal skills, and the ability to influence colleagues with ideas.
- Previous scientific and managerial experience in support of drug product development, investigations, and regulatory filings is important.
- Ability to learn and rapidly react in an environment with dynamic information.
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.
careers.amgen.comEqual 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.