Thanks!
Steve
Job Description - External:
This position's primary responsibility is to lead the Cellular Process
Development Department. This group is responsible for developing and
supporting of both microbial and mammalian based processes for the
late clinical and commercial production of recombinant proteins for
use as human therapeutics. Specific responsibilities include process
development, characterization, validation and monitoring; technology
transfer and scale-up; process troubleshooting, investigations and
change control; supporting regulatory requirements and technology
development for cell culture process. Major responsibilities of the
position include developing and implementing business and scientific
strategies; developing group goals and monitoring progress; guiding
and reviewing the groups technical output; coaching and developing
staff; developing and administering budgets and resource plans;
representing Cellular PD in various settings and participating in the
PD leadership team. The position involves extensive interactions
between various groups within and outside of process development
locally and at other Amgen sites.
Experience - External:
This position requires a Ph. D. in Chemical, Biochemical engineering,
Cell Biology or related discipline and 10+ yrs of industrial
experience. The ideal candidate will have at least 8 yrs experience in
cell culture with significant commercial product support experience
and extensive supervisory experience.
Requires excellent scientific and problem solving skills. Excellent
leadership skills are required as this position leads a growing
functional area with over 20 staff. Strong interpersonal skills are
essential as this position requires effective interactions with client
groups and remote sites. The candidate should have extensive
experience in mammalian cell culture PD and scale-up for the
production of human therapeutics. Experience with clinical or
commercial scale GMP production and regulatory interactions is
critical.