Senior Manager Drug Product Development And Manufacturing

Senior Scientist – Drug Product Development & Technology Transfer

We are seeking a highly motivated Senior Scientist to join our Drug Product Development team and play a key role in advancing innovative biologic therapies from development through commercial manufacturing. This individual will lead drug product development and technology transfer activities for sterile liquid and lyophilized biologic products, working closely with cross-functional teams and external manufacturing partners.

The ideal candidate will have strong experience in biologics formulation development, process development, CMC activities, and technology transfer within a regulated pharmaceutical or biotechnology environment. This is an exciting opportunity to have direct impact on the development and commercialization of life-changing therapies.

• Lead formulation, process development, and process characterization activities for biologic drug products.
• Design and oversee process development and characterization studies to support product development and commercialization.
• Evaluate develop ability and manufacturability of early-stage biologic candidates and provide recommendations to support candidate selection.
• Support scale-up activities and process optimization to ensure robust and manufacturable drug product processes.
• Troubleshoot technical challenges and develop scientific solutions to support program advancement.

• Lead technology transfer activities for late-stage and commercial biologic drug products at external Contract Manufacturing Organizations (CMOs).
• Provide technical oversight and support for sterile fill-finish manufacturing processes.
• Partner with external manufacturing organizations to ensure successful process implementation, scale-up, and commercial readiness.
• Support manufacturing investigations, process improvements, and process validation activities as needed.

• Collaborate with Discovery, Analytical Development, Manufacturing, Quality, Regulatory Affairs, and Program Management teams.
• Manage CRO and CMO relationships to ensure project milestones, quality standards, and timelines are achieved.
• Communicate project progress, technical risks, mitigation strategies, and recommendations to key stakeholders and leadership teams.
• Participate in cross-functional decision-making to support CMC strategy and development objectives.

• Author, review, and approve development reports, protocols, technical documents, and CMC-related documentation.
• Support regulatory submissions by providing technical documentation and development summaries.
• Ensure all activities are conducted in accordance with applicable regulatory requirements and industry best practices.

• PhD, MS, or BS in Pharmaceutical Sciences, Biochemistry, Bioengineering, Chemistry, Chemical Engineering, or a related scientific discipline.
• Minimum of:
  • 5+ years of industry experience with a PhD or MS, or
  • 10+ years of industry experience with a BS degree.
• Extensive experience in biologics formulation development and drug product process development.
• Experience supporting sterile liquid and/or lyophilized drug products.
• Strong knowledge of CMC development principles and biologics manufacturing.

• Experience working with monoclonal antibodies (mAbs) or other biologic therapeutics.
• Demonstrated success leading technology transfer activities to CMOs.
• Experience supporting sterile fill-finish operations and commercial manufacturing.
• Strong understanding of process characterization, process validation, and commercialization activities.
• Experience managing external vendors, CMOs, and CROs.
• Excellent scientific communication and technical writing skills.
• Proven ability to work effectively within cross-functional teams in a fast-paced environment.

Job Type &

Location:

This is a Contract position based out of Lexington, MA.

Pay and Benefits:

The pay range for this position is $75.00 - $90.00/hr 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 onsite position in Lexington, MA.

Final date to receive applications:
This position is anticipated to close on Aug 21, 2026.