Senior Scientist

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.

Responsibilities

• 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.

Requirements

• Bachelor’s degree in science, engineering or equivalent with 12+ years of experience working in a related pharmaceutical environment.
• Advanced degree (MS/PhD) preferred.
• Up to 15% travel will be required at times.

Skills

• Downstream process development
• MSAT
• CMC
• CDMO
• Process engineering
• Strong analytical skills
• Strong oral and written communications skills
• Ability to work in new/unstructured environments
• Experience working with contract manufacturing organizations

Pay

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

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 fully remote, contract position based out of Boston, MA.