CMC Lead, Biologics SME

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

Benefits offered by this job

Health insurance

401(k) with company match

Paid parental leave

Paid time off

Flexible spending accounts

Life and AD&D insurance

Disability coverage

Commuter benefits

Job summary

ProBio Inc., a GenScript subsidiary, seeks a CMC technical lead to guide biologics programs from development through GMP manufacturing. The role collaborates with BD, PM, and manufacturing to ensure on-time delivery and client satisfaction, including support for IND/BLA activities.

Strong leadership and English communication are essential. Responsibilities include pre-sales support, technical guidance across CMC activities, and representation at conferences to promote ProBio services to US

Qualifications

• PhD with 3+ years of industry experience or Master’s with 7+ years.
• Experience in biologics CMC including cell line development, process development, GMP manufacturing, and regulatory support.
• Experience supporting IND and/or BLA programs for antibody and protein biologics.
• Strong client-facing communication and presentation skills.
• Demonstrated ability to collaborate across BD, PM, Manufacturing and other functions.
• Strong leadership, problem-solving and project management skills.
• Commercial mindset with ability to understand customer needs and support growth.
• Excellent written and verbal communication in English.

Responsibilities

• Provide technical and project support to BD during pre-sales activities.
• Serve as CMC technical lead/SME for biologics programs across development and manufacturing.
• Collaborate with CMC teams and Project Management for timely delivery and client alignment.
• Lead technical discussions with clients to agree on scope, timelines and deliverables.
• Review proposals, project plans, and client-facing documentation.
• Serve as Project Leader for selected integrated CMC projects for US clients.
• Support client visits, conferences, and other BD activities by presenting ProBio capabilities.

Skills

Biologics CMC

Client-facing comms

Leadership

Project management

Education

PhD in Biopharmaceutical Sciences or related

Master’s degree in related field

Job description

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.

Job Description:

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.

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.

#LW

• medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• 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.
• 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.
• 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.

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.

ProBio Inc. maintains a drug-free workplace.