Associate Director, Process Engineering - Oral Solid Dosage, Clinical Manufacturing (onsite)

medhunter.de

Rahway, New Jersey, USA
Base: $142,400.00 - $224,100.00; bonus/equity: eli...
**
Oral solid dosage manufacturing
Gmp documentation review
Small-molecule gmp drug product processing
** The Associate Director, Process Engineering position at medhunter.de involves leading clinical manufacturing processes for oral solid dosage forms at their Rahway, New Jersey facility. The role emphasizes GMP compliance, team mentorship, and technical project ownership within a collaborative, innovative environment. **

Job Summary

  • The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products, leveraging pharmaceutical unit operations.
  • Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.
  • Mentor a team of 2-5 process engineers by technical coaching and developing for success through feedback and development guidance.

Matching Summary

Match Score: 75

** The Associate Director, Process Engineering position at medhunter.de involves leading clinical manufacturing processes for oral solid dosage forms at their Rahway, New Jersey facility. The role emphasizes GMP compliance, team mentorship, and technical project ownership within a collaborative, innovative environment. **

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: medical, dental, vision healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

  • Oral Solid Dosage manufacturing
  • GMP documentation review
  • small-molecule GMP drug product processing
  • cGMP, FDA, EMA regulatory requirements
  • process robustness assessments
  • root cause analysis
  • change control and deviation management

Nice-to-have

  • subject matter expert in drug delivery
  • experience in Formulation, Analytical Sciences
  • technical transfer of early-phase drug product
  • managing and developing teams
  • foster culture of collaboration, learning and innovation

Key Requirements

  • Bachelor of Science degree with minimum of 10 years relevant experience
  • Master’s degree with 8 years of relevant experience
  • PhD degree with 4 years of relevant experience
  • Experience authoring, reviewing and approving batch records
  • Proven track record in operating in a fast-paced environment
  • Demonstrated ability of independent problem-solving

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter