Remote CMC Lead & Biologics SME

ProBio; Pennington (NJ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan with company 1x

Parental leave after 3 months

Paid time off & holidays

Flexible spending accounts

Health savings accounts

Life and AD&D insurance

Disability coverage

Pet insurance

Commuter benefits

Well-being programs

Peer-to-peer recognition

Job summary

ProBio, a GenScript subsidiary, seeks a CMC technical lead to drive biologics projects from proposal to delivery, interfacing with BD, clients, and engineering teams. You will guide cell line development, process development, GMP manufacturing, and regulatory support, while advancing opportunities at conferences and client visits.

This role offers remote work flexibility from US or EU locations and requires strong leadership, communication, and program management skills to align scope,

Qualifications

• Strong client-facing communication and presentation skills.
• Proven ability to lead cross-functional teams across BD, PM, and manufacturing.
• Deep experience in biologics CMC, including cell line development, process development, GMP manufacturing, and regulatory support.
• Experience supporting IND/BLA programs for antibody and protein biologics.

Responsibilities

• Provide technical and project support to BD during pre-sales activities, including client presentations and solution development.
• Serve as the CMC technical lead/SME for biologics programs across development and manufacturing.
• Collaborate with CMC teams and PM to ensure timely delivery and alignment with client expectations.
• Lead technical discussions with clients to define scope, timelines, and deliverables.
• Review proposals, project plans, and client-facing documentation for accuracy and relevance.
• Serve as Project Leader for selected integrated CMC projects from U.S. clients.
• Support client visits, conferences, and business development activities by representing ProBio's capabilities.

Skills

Client-facing communication

Project leadership

Biologics CMC

Cross-functional collaboration

English communication

Education

Ph.D. in Biopharmaceutical Sciences

MS in related field

Job description

ProBio, a GenScript subsidiary, seeks a CMC technical lead to drive biologics projects from proposal to delivery, interfacing with BD, clients, and engineering teams. You will guide cell line development, process development, GMP manufacturing, and regulatory support, while advancing opportunities at conferences and client visits.

This role offers remote work flexibility from US or EU locations and requires strong leadership, communication, and program management skills to align scope,