Principal Scientist, Technical Director - Process Engineering - Oral Solid Dosage, Clinical Manufacturing (onsite)

539

Rahway, New Jersey, United States
$173,200.00 - $272,600.00; bonus/equity: eligible ...
Hybrid
Gmp drug product processing
Solid oral dosage forms
Process robustness and validation
The Oral Solids Dosage (Non-Sterile) team at the FLEx Center is looking for a Principal Scientist / Sr. Principal Scientist / Technical Director – Process Engineering to lead clinical supply manufacturing and scientific rigor of processes

Job Summary

  • The Oral Solids Dosage (Non-Sterile) team at the FLEx Center is looking for a Principal Scientist / Sr. Principal Scientist / Technical Director – Process Engineering to lead clinical supply manufacturing and scientific rigor of processes.
  • This role will own FLEx interactions across CMC project teams, lead development of new, innovative approaches for product and process development, and mentor a team of process engineers.
  • The successful candidate will be a passionate engineer with strong academic fundamentals and a drive to develop and improve processes focusing on robustness to ensure the highest product quality.

Matching Summary

The Oral Solids Dosage (Non-Sterile) team at the FLEx Center is looking for a Principal Scientist / Sr. Principal Scientist / Technical Director – Process Engineering to lead clinical supply manufacturing and scientific rigor of processes.

Salary

$173,200.00 - $272,600.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • GMP drug product processing
  • Solid oral dosage forms
  • Process robustness and validation
  • Root cause analysis
  • Deviation management
  • cGMP, FDA, EMA regulatory requirements

Nice-to-have

  • Drive new technology strategy
  • Scientific understanding and capability build
  • Creativity and discipline to drive results
  • Enhance professional image and competitive advantage
  • Work effectively with diverse skill sets

Key Requirements

  • Minimum 14 years relevant experience with BS degree
  • Minimum 10 years relevant experience with MS degree
  • Minimum 8 years relevant experience with PhD degree
  • Extensive knowledge and experience in GMP drug product processing
  • Proven track record in operating in a fast-paced manufacturing environment
  • Demonstrated capability in leading and coaching others
  • Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements
  • Experience supporting GMP audits
  • Ability to lead process development activities in matrix team environments

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter