For Employers

ProBio

CMC Lead, Biologics SME

Posted an hour ago
5-10 years experience
Apply Now

Please mention DailyRemote when applying

?
Resume Match Score

See how much of this job your resume covers, and what’s missing.

Want a recruiter to go through it line by line?

Get professional review

Create a cover letter for this job

Upload your resume and we draft a letter for this exact role, tailored to what it asks for.

  • Tailored to this role
  • Based on your resume
  • Fully editable
AI Summary

The incumbent will serve as the CMC technical lead for biologics programs, providing guidance across cell line development, process development, and GMP manufacturing. They will also support business development activities by engaging with clients, delivering technical presentations, and managing integrated CMC projects.

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:

  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.

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. 

Automatically Apply to the Best Remote Jobs

Stop the endless job search. Our AI finds and applies to the best jobs for you.

Try it Now
Keep looking

Similar Jobs

See all Remote Teaching jobs →

Principal, R&D Strategy & Operations

Full Time United States $171K - $251K per year Teaching

Teacher of the Visually Impaired (TVI)-CONTRACTOR

Part Time, Freelance United States Teaching

Principal Software Engineering Manager - GitHub Plan and Track (CoreAI)

Full Time United States $165K - $331K per year Teaching

Sr Principal Managing Partner

Full Time United States $163K - $235K per year Teaching

Early Careers New Grad - Leadership Development Program (REMOTE)

Full Time United States $63300 - $114K per year Teaching

Principal, Corporate Governance & Board Engagement

Full Time United States $138K - $150K per year Teaching
Apply Now

Personalize your Remote Job Search in 3 Easy Steps!

Featuring 219,280+ Jobs in Teaching

Answer easy questions

Answer easy questions

219,280+ jobs across 15+ categories

Get your best job matches

Get your best job matches

Only hand-screened, legit jobs

Find a remote job faster

Find a remote job faster

No ads, scams, or junk

“I was the first applicant for a remote marketing position that got listed on the company website the same day I applied. Had an interview within 48 hours!”

Sarah J. — Sarah J. · Marketing Manager ★★★★★ Verified