Senior Manager, CMC

About the role

Lead tech transfer activities for late-phase and commercial manufacturing of sterile liquid and lyophilized biologics drug products at CMOs. Design process development and characterization studies, and perform or oversee study execution. Conduct developability and manufacturability studies for early-phase lead candidates and collaborate with the Discovery team to support drug candidate selection. Author and review study protocols and reports and other CMC documentation. Summarize and communicate project updates, risks, and recommendations to stakeholders. Manage external partners (CROs/CMOs) to advance project milestones.

Requirements

• PhD or MS or BS in pharmaceutical sciences, biochemistry, bioengineering, chemistry, or a related discipline
• 5+ years (PhD/MS) or 10+ years (BS) of hands-on experience in biologics formulation development and drug product process development
• Experience with monoclonal antibodies or other biologic drug products, including sterile liquid and/or lyophilized products
• Demonstrated experience managing CMOs for sterile biologic drug product technology transfer, process development, and sterile fill/finish manufacturing

Pay

The pay range for this position is $75.00 - $90.00/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

• Contract position
• Fully onsite in Lexington, MA