Remote CMC Lead for Biologics — Client-Facing SME & Lead

GenScript/ProBio; Pennington (NJ); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company 1:

Paid parental leave

Paid time off (vacation, personal, and

Sick time, holidays

Flexible spending accounts

Health savings accounts

Life and AD&D insurance

Disability coverage

Commuter benefits

Well-being programs

Peer-to-peer recognition

Job summary

GenScript USA Inc./ProBio Inc. seeks a senior CMC leader to guide biologics programs from proposal through delivery, interfacing with client teams and BD. This role leads cell line development, process development, GMP manufacturing, and regulatory support with a strong client-facing focus.

The position offers remote work from US or EU locations, with responsibilities spanning technical leadership, BD engagement, and cross-functional collaboration to meet IND/BLA milestones.

Qualifications

• Ph.D. in Biopharmaceutical Sciences or related field with 3+ years industry experience, or a Master’s degree with 7+ years industry experience.
• Strong experience in biologics CMC, including cell line development, process development, GMP manufacturing, and regulatory support.
• Demonstrated track record supporting IND and/or BLA programs for antibody and protein biologics.
• Strong client-facing communication and presentation skills, with the ability to translate complex technical information into clear recommendations.
• Demonstrated ability to collaborate effectively across BD, Project Management, Manufacturing, and other technical functions.
• Strong leadership, problem-solving, and project management skills.
• Commercial mindset with the ability to understand customer needs and support business growth.
• Excellent written and verbal communication skills in English.

Responsibilities

• Provide technical and project support to BD during pre-sales activities, including client presentations, technical discussions, and solution development to improve opportunity-to-order conversion.
• Serve as the CMC technical lead/SME for biologics programs, providing technical guidance across cell line development, process development, GMP manufacturing, and related CMC activities.
• Collaborate with CMC functional teams and Project Management to ensure successful project execution, timely delivery, and alignment with client expectations.
• Lead technical discussions with clients and ensure alignment on project scope, strategy, timelines, technical requirements, and deliverables.
• Review and provide technical input on proposals, project plans, and client-facing documentation.
• Serve as Project Leader for selected integrated CMC projects from U.S. clients.
• Support client visits, conferences, and other business development activities by representing ProBio’s technical capabilities and service offerings.

Skills

Client-facing communication

Leadership

Project management

Biopharma industry knowledge

Presentation skills

Education

PhD in Biopharmaceutical Sciences

Master's degree in related field

Job description

GenScript USA Inc./ProBio Inc. seeks a senior CMC leader to guide biologics programs from proposal through delivery, interfacing with client teams and BD. This role leads cell line development, process development, GMP manufacturing, and regulatory support with a strong client-facing focus.

The position offers remote work from US or EU locations, with responsibilities spanning technical leadership, BD engagement, and cross-functional collaboration to meet IND/BLA milestones.