CMC Lead, Biologics SME

Posted 7 Days Ago
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Hiring Remotely in United States
Remote
Senior level
Biotech
The Role
Leads biologics CMC projects from proposal through completion, serving as the technical SME across cell line development, process development, GMP manufacturing, and regulatory support. Supports business development through client presentations, solution development, proposals, conferences, and client visits. Coordinates with CMC, project management, manufacturing, and commercial teams to define scope, strategy, timelines, deliverables, and successful project execution.
Summary Generated by Built In
About GenScript

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:

  1. 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.
  2. 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.
  3. Collaborate with CMC functional teams and Project Management to ensure successful project execution, timely delivery, and alignment with client expectations.
  4. Lead technical discussions with clients and ensure alignment on project scope, strategy, timelines, technical requirements, and deliverables.
  5. Review and provide technical input on proposals, project plans, and client-facing documentation.
  6. Serve as Project Leader for selected integrated CMC projects from U.S. clients.
  7. Support client visits, conferences, and other business development activities by representing ProBio’s technical capabilities and service offerings.

Qualifications:

  1. 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.
  2. Strong experience in biologics CMC, including areas such as cell line development, process development, GMP manufacturing, and regulatory support.
  3. Demonstrated track record supporting IND and/or BLA programs for antibody and protein biologics.
  4. Strong client-facing communication and presentation skills, with the ability to translate complex technical information into clear recommendations.
  5. Demonstrated ability to collaborate effectively across BD, Project Management, Manufacturing, and other technical functions.
  6. Strong leadership, problem-solving, and project management skills.
  7. Commercial mindset with the ability to understand customer needs and support business growth.
  8. Excellent written and verbal communication skills in English.


#PB

#LW

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. 

Skills Required

  • Ph.D. in Biopharmaceutical Sciences or a related field with at least 3 years of relevant industry experience, or a Master's degree with at least 7 years of relevant industry experience.
  • Strong experience in biologics CMC, including cell line development, process development, GMP manufacturing, and regulatory support.
  • Demonstrated experience supporting IND and/or BLA programs for antibody and protein biologics.
  • Strong client-facing communication and presentation skills, including the ability to translate complex technical information into clear recommendations.
  • Ability to collaborate effectively across business development, project management, manufacturing, and technical functions.
  • Strong leadership, problem-solving, and project management skills.
  • Commercial mindset and ability to understand customer needs and support business growth.
  • Excellent written and verbal communication skills in English.

GenScript Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GenScript and has not been reviewed or approved by GenScript.

  • Healthcare Strength — Feedback suggests medical coverage is solid, with mentions of comprehensive health plans and employer HSA support in some options. Company communications also emphasize robust health benefits alongside wellbeing and training initiatives.
  • Leave & Time Off Breadth — Feedback suggests a range of paid time off types, including vacation, sick time, company holidays, and additional leave categories. Some roles reference flexible vacation arrangements that broaden usable time off.
  • Retirement Support — Feedback suggests retirement offerings include a 401(k) with company match in certain postings. This provides a longer-term savings component within total rewards.

GenScript Insights

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The Company
HQ: Piscataway, NJ
883 Employees
Year Founded: 2002

What We Do

Founded in 2002 and listed on the Hong Kong Stock Exchange in 2015, GenScript has an established global presence across Greater China, North America, the EU, and Asia Pacific. Today, over 300,000 customers from over 160 countries and regions worldwide have used GenScript’s premier, convenient, and reliable products and services. GenScript currently has over 5,000 employees globally, 33% holding master’s and/or Ph.D. degrees. In addition, GenScript has a number of leading commercial technologies developed in the fields of synthetic biology, immunotherapy, antibody design, chemical synthesis, and bioinformatics, including more than 100 patents and over 270 patent applications. As of June 2022, GenScript's products and services have been cited by 74,700 scientific papers worldwide. GenScript is committed to striving toward its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

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