Senior Scientist - MSAT - Downstream Processes

Actalent; United States; Remote; USD 92,000 - 113,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life insurance

PTO/Time off

Job summary

Actalent is seeking a Sr. Scientist to lead downstream process control strategy implementation with external CDMOs and enable robust validation approaches for regulatory licensure. You will develop scale-down models, set critical process parameters, and drive technology transfers within a cross-functional team.

The role emphasizes hands-on process development, risk assessment, and collaboration across functions to advance gene therapy workflows while working remotely with periodic travel.

Qualifications

• Strong knowledge of downstream biologics process development.
• Experience with late-stage characterization and process validation.
• Familiarity with external CDMOs and regulatory submissions.

Responsibilities

• Lead phase-appropriate downstream control strategies at external CDMOs.
• Conduct pre-validation risk assessments using risk tools.
• Provide scale-down models for process characterization.
• Establish critical process parameters and validation strategy.
• Support Tech Ops to optimize 2nd generation processes and reduce costs.
• Collaborate on new product commercialization, improvements and tech transfers.
• Assist with regulatory filings, including BLA process validation.

Skills

Downstream process development

Late-stage process characterization

CMO/CDMO experience

Module 3 authoring

Education

Bachelor's degree in science/engineering

MS/PhD preferred

Tools

BLA submissions

Job description

Job Title: 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)
• Experience with Module 3 authoring and support for BLA submissions

Additional Skills & Qualifications

• Bachelors 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 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 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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 9, 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 ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.