Director Process Development - Purification Process Engineering

Location: West Greenwich

Director Process Development - Purification Process Engineering page is loaded## Director Process Development - Purification Process Engineering remote type:
On Site locations:
US - Rhode Island - West Greenwichtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
R-236851##
** Career Category
** Operations## ##
** Job Description
**** Join Amgen’s Mission of Serving Patients
** At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
** Director Process Development - Purification Process Engineering
**** What you will do
** Let’s do this. Let’s change the world. In this vital role you will lead the
** Purification Process Engineering
** function within Process development organization. In this role you will be responsible for technical guidance of commercial Drug Substance operations within a high mix, multiproduct manufacturing facility. This includes technical transfer and scale up of processes, deployment of novel manufacturing technologies and troubleshooting biologics manufacturing processes.

The successful candidate will serve as the primary process development point of contact with key leadership partners in Manufacturing and Quality. This leader will ensure that process engineering deliverables including new process introduction; implementation of new technologies;
Process Performance Qualification (PPQ) and ongoing monitoring and support of drug substance production are managed and completed. They will have an entrepreneurial approach with ambition to drive innovation and plant efficiency through exploration of process, technology and capacity improvement opportunities. The Director ensures group’s outputs are safe, compliant, and aligned with plant performance goals.

Additional Responsibilities:
* Provide leadership and subject matter expertise in bioprocess purification disciplines including chromatography and filtration operations. Good knowledge of quality, regulatory and development requirements for large molecule manufacturing.
* Support process scale-up and technology transfer to production facilities. Partners closely with development teams to ensure successful transfer of knowledge to process teams during technical transfers.
* Lead a successful team committed to finding innovative ways to maximize team engagement and ensure the team reaches its full potential.
* Lead multi-functional teams to resolve complex technical problems while meeting quality, schedule, and cost objectives.
* Serve as member of Drug Substance Technology extended leadership team and utilize network thinking and advancing the process development function.
* Engage with the manufacturing and process development network to assess technology and to improve facility capacity and capability.
** What we expect of you
** We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a leader with these qualifications.
*
* Basic Qualifications:

*** Bachelor’s degree and 10 years of Process Development, Engineering or Manufacturing experience
** OR
* ** Master’s degree and 8 years of Process Development, Engineering or Manufacturing experience
** OR
* ** Doctorate degree and 4 years of Process Development, Engineering or Manufacturing experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience…