Biologics Downstream Director - Commercialization

Jobtailor; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Jobtailor seeks a senior downstream biology leader in New Jersey to guide late-stage and commercial programs. The role will oversee laboratory-scale and manufacturing-scale studies, ensuring transfer of process knowledge and regulatory compliance across core unit operations.

Lead a cross-functional team, drive process development, characterization, and validation efforts, and mentor scientists. Emphasizes innovation, lifecycle management, and collaboration with internal and external partners to

Qualifications

• Deep downstream biologics expertise with process development ownership.
• Experience supporting late-stage development and commercialization.
• Leadership in cross-functional, matrixed organizations.
• Ability to design and document all stages of process development.
• Strong track record in technology transfer and scale-up.
• Regulatory submission writing experience preferred.
• Lean leadership and operational excellence mindset.
• Willingness to travel up to 10%.

Responsibilities

• Lead downstream biologics teams for late-stage and commercial programs.
• Provide technical leadership for lab and manufacturing-scale studies.
• Serve as downstream SME across unit operations and interdependencies.
• Ensure knowledge transfer aligned with regulatory expectations.
• Support technology transfer to internal/external sites, scale-up and validation.
• Contribute to lifecycle management and investigations for commercial processes.
• Author and review regulatory and technical documentation.
• Drive biologics manufacturing initiatives and platform evolution.
• Collaborate with stakeholders and CDMOs; mentor downstream staff.
• Promote innovation, continuous improvement, and operational excellence.

Skills

Leadership

Cross-functional collaboration

Strategic problem solving

Coaching and mentoring

Regulatory communication

Lean leadership

Analytical thinking

Written and verbal communication

Travel willingness

Education

BS/MS/PhD in Chemical Engineering or related

Tools

Preparative chromatography

Tangential flow filtration

Virus retentive filtration

Process characterization

PPQ and validation

Regulatory submission support

Technology transfer

Scale-up and manufacturing readiness

Job description

Jobtailor seeks a senior downstream biology leader in New Jersey to guide late-stage and commercial programs. The role will oversee laboratory-scale and manufacturing-scale studies, ensuring transfer of process knowledge and regulatory compliance across core unit operations.

Lead a cross-functional team, drive process development, characterization, and validation efforts, and mentor scientists. Emphasizes innovation, lifecycle management, and collaboration with internal and external partners to