Senior Scientist

Description Job Title: Senior Scientist - Downstream Process Sciences Serve as a liaison to CMC teams to shepherd new pipeline products from development into manufacturing. This includes collaborating with downstream process engineers and development scientists to adapt pipeline assets to client's next generation downstream manufacturing platform and transfer robust processes to commercial and third-party manufacturing operations. • Lead the implementation of phase appropriate downstream process control strategies by following the FDA guidance and QbD to enable effective validation strategies at external CDMOs. • Provide technical expertise to pre-validation risk assessments using risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented. • Provide technical expertise for establishing qualified scale down models of the downstream process to enable process characterization. • Provide technical expertise for establishing critical process parameters and a process validation strategy that supports product licensure including design and oversight of process characterization activities ensuring robust operational range finding studies and establishment of appropriate NORs and PARs for in process controls. • Support Tech Ops team in optimizing 2nd generation downstream processes targeting reduced COGs and improved manufacturability, timelines, and development plans in collaboration with broader global team including project management, MS&T, Process Development, Analytical Development/QC, QA, and regulatory members. • Integrate cross-functional and/or external information and apply technical knowledge to data-driven decision-making • Collaborate with a cross-functional team to support new product commercialization, process improvements, and technology transfers between internal and external manufacturing sites. •Assist in the technical aspects of the company’s regulatory filings, including process validation for BLA filings. Skills Downstream process development, MSAT, CMC, CDMO, process engineering, downstream process Top Skills Details Downstream process development,MSAT,CMC,CDMO,process engineering Additional Skills & Qualifications Bachelor’s degree in science, engineering or equivalent with 12+ years of experience working in a related pharmaceutical environment. Advanced degree (MS/PhD) preferred. Preferred Skills: •Strong analytical skills •Strong oral and written communications skills •Ability to work in new/unstructured environments •Experience working with contract manufacturing organizations Up to 15% travel will be required at times Experience Level Expert Level 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. Application Deadline This position is anticipated to close on Aug 21, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.