Scientist, Sterile Drug Product Commercialization-2

Newyorkbioconnect

Base: $87,300.00 - $137,400.00; bonus/equity: elig...
Hybrid
Sterile drug product process development
Technology transfer to manufacturing sites
Process validation and regulatory submissions
The Sterile Drug Product Commercialization group provides technical process leadership and laboratory capabilities for late stage and commercial drug product processes for large molecule and sterile Pharmaceutical products

Job Summary

  • The Sterile Drug Product Commercialization group provides technical process leadership and laboratory capabilities for late stage and commercial drug product processes for large molecule and sterile Pharmaceutical products.
  • Responsibilities include serving on cross-functional drug product working groups, supporting activities through filing and Process Performance Qualification (PPQ), and ensuring commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
  • The company offers a comprehensive package of benefits including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and compassionate and sick days.

Matching Summary

The Sterile Drug Product Commercialization group provides technical process leadership and laboratory capabilities for late stage and commercial drug product processes for large molecule and sterile Pharmaceutical products.

Salary

Base: $87,300.00 - $137,400.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Sterile drug product process development
  • Technology transfer to manufacturing sites
  • Process validation and regulatory submissions
  • Scale-down model development
  • Control strategy development

Nice-to-have

  • High performance culture
  • Out of the box thinking
  • Innovation and learning
  • Diversity and inclusion

Key Requirements

  • B.S. with 2 years relevant experience or Master's degree
  • Excellent oral and written communication skills
  • Ability to articulate process science understanding
  • Technical experience in large molecules drug product fill finish
  • Working knowledge of cGMPs for sterile dosage forms
  • Working knowledge of statistical methods for DOE and data analysis

Work Rights

Not specified

Tailored Resume

Cover Letter