(Remote) Downstream Senior Scientist

About the Role

As a Sr. Scientist, you will lead the implementation of phase-appropriate downstream process control strategies, adhering to FDA guidance and Quality by Design (QbD) principles. You will enable effective validation strategies at external contract development and manufacturing organizations (CDMOs). Your role includes conducting pre-validation risk assessments using risk management tools, providing qualified scale-down models of the downstream process for process characterization, and establishing critical process parameters to support product licensure.

Responsibilities

• Lead the implementation of phase-appropriate downstream process control strategies at external CDMOs.
• Conduct pre-validation risk assessments using risk management tools.
• Provide qualified scale-down models of the downstream process to enable process characterization.
• Establish critical process parameters and a process validation strategy that supports product licensure.
• Support Tech Ops team in optimizing 2nd generation downstream processes targeting reduced costs and improved manufacturability.
• Collaborate with a cross-functional team for new product commercialization, process improvements, and technology transfers.
• Assist with regulatory filings, including process validation for BLA filings.

Qualifications

• Bachelor’s degree in science, engineering, or equivalent with 12+ years of experience in a related pharmaceutical environment.
• Advanced degree (MS/PhD) preferred.

Skills

• Deep knowledge of downstream process development and pharmaceutical manufacturing for biologics.
• Experience in late-stage process characterization.
• Experience with contract manufacturing organizations (CMO/CDMO).

Work Environment

This position is fully remote with up to 15% travel required at times. The role is ideal for someone who enjoys hands-on process development work and wants to be part of a growing team. Employees are encouraged to take ownership of experiments, contribute ideas, and directly influence the development of gene therapy processes while having access to support and mentorship.

Job Type & Location

This is a Contract to Hire position based out of Boston, MA.

Pay

The pay range for this position is $67.00 - $82.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental, and vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation, or Sick Leave)

Note: Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.