Biologics CMC Lead & Client-Impact SME

ProBio; United States; On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Parental leave

Paid time off

Job summary

ProBio is seeking a senior Biopharma professional to lead the orderly progression of biologics projects from proposal through completion, interfacing with clients, technical teams, and business development. You will promote ProBio’s services at conferences and ensure alignment of scope, timelines and deliverables with client expectations.

The role requires a Ph.D. in Biopharmaceutical Sciences or an equivalent MS with extensive industry experience, strong CMC expertise, and proven IND/BLA

Qualifications

• Ph.D. in Biopharmaceutical Sciences or a related field with 3+ years of industry experience, or a Master’s with 7+ years of 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 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 and solution development.
• Serve as the CMC technical lead/ SME for biologics programs, guiding cell line development, process development, GMP manufacturing, and related CMC activities.
• Collaborate with CMC teams and Project Management to ensure timely delivery and alignment with client expectations.
• Lead technical discussions with clients and define project scope, timelines, and deliverables.
• Review and provide input on proposals, project plans, and client-facing documents.
• Serve as Project Leader for selected integrated CMC projects from U.S. clients.
• Support client visits and conferences by representing ProBio’s capabilities and services.

Skills

Biologics CMC

Cell line development

Process development

GMP manufacturing

Regulatory support

IND/BLA support

Client-facing

Leadership

Project management

English proficiency

Education

PhD in Biopharmaceutical Sciences or related (3+ yrs)

MS in related field (7+ yrs)

Job description

ProBio is seeking a senior Biopharma professional to lead the orderly progression of biologics projects from proposal through completion, interfacing with clients, technical teams, and business development. You will promote ProBio’s services at conferences and ensure alignment of scope, timelines and deliverables with client expectations.

The role requires a Ph.D. in Biopharmaceutical Sciences or an equivalent MS with extensive industry experience, strong CMC expertise, and proven IND/BLA