Process Development Principal Engineer

  • Amgen
  • Newbury Park, Thousand Oaks, CA, USA
  • Jun 21, 2022

Job Description

HOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming oneof the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Process Development Principal EngineerLiveWhat you will doLets do this. Lets change the world. In this vital role you will provide technical and project leadership while integrating information generated by functionally teams with varied strengths 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 complementary teams working optimally 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.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.Basic Qualifications:Doctorate degree & 2 years of Engineering and/or Operations experience ORMasters degree & 6 years of Engineering and/or Operations experience ORBachelors degree & 8 years of Engineering and/or Operations experience ORAssociates degree and 10 years of Engineering and/or Operations experience ORHigh school diploma / GED and 12 years of Engineering and/or Operations experiencePreferred Qualifications:Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related subject area5+ 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 authoringLeadership 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.ThriveSome of the vast rewards of working hereAs 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.Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. 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.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.Amgen requires all staff in the United States, Puerto Rico and Canada 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.
Associated topics: bioengineering, bioinformatic, biological engineer, bioprocess, biosynthetic, fermentation, hereditary, metabolic, pain, pathogenesis