The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality Drug Product development and clinical manufacturing facility focusing on right-first-time manufacture and delivery of high quality non-sterile drug products
Job Summary
The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality Drug Product development and clinical manufacturing facility focusing on right-first-time manufacture and delivery of high quality non-sterile drug products.
This role will lead clinical supply manufacturing, scientific rigor of processes, and enable flexibility and speed of the company's pipeline, while mentoring a team of process engineers.
The successful candidate will own FLEx interactions across CMC project teams, assess manufacturability of formulations, and lead development of new, innovative approaches for product and process development.
Matching Summary
The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality Drug Product development and clinical manufacturing facility focusing on right-first-time manufacture and delivery of high quality non-sterile drug products.
Salary
$173,200.00 - $272,600.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
GMP drug product processing
solid oral dosage forms
process robustness & validation
root cause analysis
deviation management
cGMP, FDA, EMA regulatory requirements
Nice-to-have
scientific rigor of processes
new technology strategy
operational and technical excellence
creativity to drive results
advancing science and technology development
Key Requirements
Bachelor of Science degree with 14 years relevant experience
Master’s degree with 10 years of relevant experience
PhD degree with 8 years of relevant experience
Extensive knowledge in GMP drug product processing
Proven track record in fast-paced manufacturing environment
Demonstrated capability in leading and coaching others