Process Development Principal Scientist: Pivotal Drug Product Technologies
Thousand Oaks, California
Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT
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Career Category Scientific 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 one of 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 Scientist: Pivotal Drug Product Technologies (DPT) Live What you will do Lets do this. Lets change the world. In this vital role you will provide technical and project leadership while integrating information generated by cross-functional teams to ensure success through the commercialization process. – Oversight of late-stage biologics drug product formulation and fill/finish process development. – Lead cross-functional Drug Product Commercialization Teams responsible for formulation development, fill/finish process development / characterization, technology transfer and regulatory authoring for pipeline and lifecycle management projects. – Lead all aspects of and engage in the planning, design, execution, and documentation of formulation and fill/finish process development studies. – Lead a team of engineers and scientists to advance program and functional objectives. – Participate and lead global cross-functional teams working optimally in a highly matrixed team environment to motivate change, efficiency and positive relationships. – Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of INDA and marketing application submissions. – Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering. – Serve as subject matter authority in DPT and help drive standard methodologies and technical advancements – Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, strategy and future program and functional needs. – Expand the utilization of complex IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis Win 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 hard-working with these qualifications. – Doctorate degree and 3 years of scientific experience OR Masters degree and 6 years of scientific experience OR Bachelors degree and 8 years of scientific experience – Advanced degree in Engineering, Pharmaceutics, Biotechnology or Material Science is preferred – 10+ years of post-PhD experience including 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 professionals with demonstrated results driving forward pipeline and lifecycle management programs. – Hands-on experience bringing new biotech products to market, across various dosage forms and device delivery systems. – Experience with advanced drug delivery for biologics including sustained release, nasal, pulmonary, or dermal delivery. – Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings. – Problem solving proficiency and effective cross-functional communication skills and ability to influence colleagues with ideas. – Scientific and managerial experience in support of drug product development, investigations, and regulatory filings is important. – Ability to learn and act on dynamic information at a rapid pace – Demonstrated track record of publication, patents and presentations. Thrive Some of the vast rewards of working here 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. – Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey – A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act – Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. #Operations21 Equal 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. .