CMC Lead, Biologics 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, 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

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.

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.

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

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in ProBio’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.