Senior Engineer - Drug Product Tech Transfer Lead
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.
Senior Engineer Drug Product Tech Transfer leadLive
What you will doLets do this. Lets change the world. In this vital role you will join Amgens Drug Product Process Engineering team, and will be a key contributor to drug product process development, commercialization, and life cycle management of Amgens parenteral product portfolio. The Senior Engineer will lead the technology transfers of Amgen drug products across all commercialization development phases and various parenteral modalities.
As the technology transfer lead, you must successfully integrate the knowledge and information generated by multi-functional teams with Amgens platforms and clinical and/or commercial facilities capabilities to ensure success through the commercialization lifecycle. You will operate in product/process development and aseptic manufacturing environments in a highly matrix multi-functional manner.Role Responsibilities:
Support technology transfers of early pipeline (FIH) to commercial products, including lifecycle management, for a variety of parenteral modalities:
Conduct make-a-batch exercises to resolve facility fit and identify gaps
Design and production of offline and on-site drug product characterization studies
Evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes
Author and/or own high-quality process technology transfer and other technical documents
Participate in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities across the parenteral portfolio
Work directly with clinical and commercial manufacturing in support of ongoing production, new product introductions, new technology introduction, and process optimization
Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering (equipment, automation, chemical, mechanical) principles to support non-conformance investigations and development of corrective/preventive actions
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
Participate in global multi-functional teams, working effectively in a highly matrixed team environment to advance technology transfer projects as well as improvement initiatives
Deliver progress reports and presentations (including generation and upkeep of dashboard) to engage with and ensure that management is aware of the current status and progress
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The agile professional we seek is an engineer with these qualifications.
Masters degree and 3 years of Operations or Process Development experience
Bachelors degree and 5 years of Operations or Process Development experience
Associates degree and 10 years of Operations or Process Development experience
High school diploma / GED and12 years of Operations or Process Development experience
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related subject area
5 plus years of drug product process development experience in the pharmaceuticals/biotechnology industry
Technology transfer experience across different development phases, fill-finish process scale-up, and the use of gap analysis, root cause analysis, and risk assessment tools
Knowledge of aseptic processing, drug product manufacturing unit operations such as formulation, filling, lyophilization, capping, visual inspection, isolators, primary containers such as vials, syringes, cartridges, devices, disposables, and relevant cGMP regulations
Experience with conducting statistical evaluations of data to assess statistical significance, potential correlations, process capability and/or perform Monte Carlo simulations
The ability to use engineering principles to demonstrate bench and pilot scale models for process performance characterization
Knowledge of bringing new biotech products to market, across various dosage forms and delivery systems
Experience with clinical and marketing application regulatory filings
Problem solving and strong communication skills
Strong experience in a matrix team environment, interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality
Ability to learn and act on dynamic information at a rapid pace
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
for a career that defies imagination
Objects in your future are closer than they appear. 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.