Senior Scientist

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

Disability (Short & Long-term)

HSA

Transportation benefits

Employee Assistance Program

Time Off / PTO

Job summary

Actalent is seeking a Sr. Scientist to lead phase-appropriate downstream process control strategies and enable validation strategies at external CDMOs. The role includes risk assessments, scale-down models, CPP establishment, and supporting BLA submissions.

This fully remote contract position is based out of Boston, MA with up to 15% travel, offering competitive hourly pay and comprehensive benefits. You will work with cross-functional teams on gene therapy processes and technology transfers.

Qualifications

• Requires 12+ years in a pharma environment.
• Experience with BLA submissions and regulatory filings.
• Remote-friendly role with global CDMO collaboration.

Responsibilities

• Lead downstream process control strategies at external CDMOs.
• Perform pre-validation risk assessments using risk tools.
• Provide qualified scale-down models for process characterization.
• Establish CPPs and a validation strategy for licensure.
• Support Tech Ops to optimize 2nd generation downstream processes.
• Collaborate across functions for new product launches and tech transfers.
• Assist with regulatory filings, including BLA process validation.

Skills

Downstream process development

Biologics manufacturing

Late-stage characterization

CMO/CDMO experience

Module 3 authoring

Education

Bachelor's in science/engineering

MS/PhD preferred

Job description

Job Title: Sr. Scientist

Job Description

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.

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.

Application Deadline

This position is anticipated to close on Oct 9, 2026.

About Actalent

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.