Remote CMC Lead & Biologics SME

GenScript Biotech Corp.; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Dental and vision insurance

401(k) with company match

Parental leave

Paid time off

FSAs/HSA

Life and AD&D insurance

Disability coverage

Legal assistance

Pet insurance

Critical illness

Accident insurance

Hospital indemnity

Commuter benefits

Well-being initiatives

Peer recognition program

Job summary

GenScript Biotech Corporation, through its ProBio unit, seeks a CMC Project Leader to steer biologics programs from proposal to delivery. You will guide cell line and process development, GMP manufacturing, and regulatory support while engaging with BD and clients to shape scope and timelines.

The role emphasizes cross-functional leadership, strategic communication, and hands-on project management in a remote-friendly work setup across US/EU regions.

Qualifications

• Ph.D. in Biopharmaceutical Sciences or related field with 3+ years of industry experience, or a Master’s with 7+ years of industry experience.
• Strong experience in biologics CMC, including cell line development, process development, GMP manufacturing, and regulatory support.
• Proven 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 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

PhD in Biopharmaceutical Sciences or a

Client-facing communication

Leadership

Project management

Collaboration across functions

Regulatory support

IND/BLA experience

English proficiency

Commercial mindset

Problem-solving

Education

PhD in Biopharmaceutical Sciences or related field

Master’s degree in related field

Job description

GenScript Biotech Corporation, through its ProBio unit, seeks a CMC Project Leader to steer biologics programs from proposal to delivery. You will guide cell line and process development, GMP manufacturing, and regulatory support while engaging with BD and clients to shape scope and timelines.

The role emphasizes cross-functional leadership, strategic communication, and hands-on project management in a remote-friendly work setup across US/EU regions.