The Sr Manager/Associate Director, Manufacturing will provide manufacturing operational and technical leadership throughout commercial ramp up and expansion
Job Summary
The Sr Manager/Associate Director, Manufacturing will provide manufacturing operational and technical leadership throughout commercial ramp up and expansion.
This individual will be responsible for initially managing up to 16 direct labor manufacturing personnel for GMP production and lead a significant hiring ramp based on regulatory approvals.
The ideal candidate will be a seasoned leader with a demonstrated track record of building and managing high performing teams and possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships.
Matching Summary
The Sr Manager/Associate Director, Manufacturing will provide manufacturing operational and technical leadership throughout commercial ramp up and expansion.
Salary
$155,000—$225,000 USD
Skills & Requirements
Must-have
GMP production
commercial ramp up
hiring and development of staff
operating plans, procedures, systems
training plans
multidisciplinary teams
cross-functional relationships
cGMP Manufacturing
safety, compliance, efficiency, sustainability
quality standards
departmental budget
workforce model
manufacturing schedules
product supply forecasts
program timelines
manufacturing project plans
electronic batch records implementation
commercial expansion activities
manufacturing documents
deviation investigations
change controls / CAPAs
facility and equipment design
qualification
work onsite daily
Nice-to-have
cell therapy commercialization
scale out
MES implementation
learning culture
innovation and continuous improvement
long range and business continuity plans
metrics/KPIs
empowered teams
patients first
diverse teams
audits and regulatory inspections
after hours support
Key Requirements
Bachelor’s degree in science or engineering
10 years of Manufacturing and Operations experience
2 years experience leading and developing people in a GMP setting