Senior Scientist - MSAT - Downstream Processes

We are seeking an experienced and highly motivated Sr Scientist, Downstream Process Sciences - MSAT to provide technical leadership for downstream manufacturing processes supporting a growing biologics pipeline. This role will drive process characterization, technology transfer, process validation, and manufacturing readiness activities while partnering closely with internal stakeholders and external manufacturing organizations.

Responsibilities

• Serve as a technical liaison between CMC, Process Development, Manufacturing, and external partners to successfully transition pipeline products from development into manufacturing.
• Lead downstream process transfer activities and support implementation of robust manufacturing processes at commercial and contract manufacturing sites.
• Develop and implement phase-appropriate process control strategies utilizing Quality by Design (QbD) principles and regulatory guidance.
• Design and oversee process characterization studies and establish qualified scale-down models to support process understanding and validation activities.
• Lead risk assessments and ensure process risks are effectively identified, evaluated, mitigated, and documented.
• Establish critical process parameters (CPPs), normal operating ranges (NORs), proven acceptable ranges (PARs), and process validation strategies.
• Support manufacturing optimization initiatives to improve process robustness, manufacturability, efficiency, and cost of goods.
• Collaborate cross-functionally with MSAT, Process Development, Analytical Development, Quality, Regulatory Affairs, and Project Management teams.
• Support technology transfers between internal and external manufacturing sites.
• Contribute to regulatory submissions and provide technical support for process validation activities related to product commercialization.
• Analyze process data and leverage scientific insights to drive data-based decision making and continuous improvement.

Qualifications

• Required Bachelor's degree in Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline.
• 12+ years of experience in pharmaceutical, biotechnology, biologics, or related manufacturing environments.
• Strong expertise in downstream process development and commercial biomanufacturing.
• Experience supporting process characterization, process validation, and technology transfer activities.
• Experience working with CDMOs and external manufacturing partners.
• Comprehensive understanding of cGMP regulations and pharmaceutical manufacturing requirements.
• Strong project management and cross-functional collaboration skills.
• Preferred Advanced degree (MS or PhD) in a scientific or engineering discipline.
• Experience supporting biologics manufacturing and commercialization programs.
• Strong analytical, technical writing, and presentation skills.
• Ability to thrive in a fast-paced and evolving environment while managing multiple priorities.

Skills

• Downstream Process Development
• Manufacturing Sciences & Technology (MSAT)
• CMC
• Process Engineering
• Process Characterization
• Process Validation
• Technology Transfer
• CDMO Management
• Biologics Manufacturing
• Risk Assessments
• Regulatory Support
• Quality by Design (QbD)

Pay

The pay range for this position is $67.00 - $82.00/hr.

Benefits

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)

Schedule

• This is a Contract position based out of Boston, MA.
• Travel: Up to 15%
• Workplace Type: Fully remote position.