Senior Scientist-downstream Process Development

Sr. Scientist

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.

Essential 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).

Additional Skills & Qualifications

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

Work Environment

This position is fully remote with up to 15% travel required  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 position based out of Boston, MA.

Pay and Benefits

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. 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.

If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & 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)

Workplace Type

This is a fully remote position.

Final date to receive applications

This position is anticipated to close on Sep 15, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a Clearly Rated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information…