CMC Lead, 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

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About ProBio:

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

About the job

The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting Probio’s services at conferences/trade shows. This position will offer the candidate flexibility working remotely from home in US or EU locations.

Key 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.

Qualifications

• Ph.D. in Biopharmaceutical Sciences or a related field with 3+ years of relevant industry experience, or a Master’s degree with 7+ years of relevant industry experience.
• Strong experience in biologics CMC, including areas such as 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.

Benefits

• Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays.
• Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.