Kernal Biologics
Vice President of Chemistry Manufacturing and Controls (VP of CMC)
Kernal Biologics, Boston, Massachusetts, us, 02298
Vice President of Chemistry Manufacturing and Controls (VP of CMC)
About Kernal Biologics, Inc.
Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents. With support from leading investors, including Hummingbird Ventures, Amgen Ventures, Y Combinator, and HBM, Kernal Bio is transforming the future of cell therapy design and delivery. Job Summary Kernal Bio is seeking a highly motivated and experienced Vice President of Chemistry Manufacturing and Controls (VP of CMC) or Director of Process Development with expertise in mRNA manufacturing to contribute to the development of its mRNA 2.0 platform for therapeutic applications. The successful candidate will inspire and lead a team responsible for the manufacturing, process development, and analytical development of mRNA LNP therapeutics. Proficiency in mRNA LNP chemistry and biology workflows, coupled with experience in Good Manufacturing Practices (GMP) mRNA LNP manufacturing, is essential for this role.
Lead the CMC team and guide the company\'s drug substance and drug product manufacturing strategy
Work with senior management to expand the company\'s CMC team
Stay up-to-date on pertinent literature and prepare technical reports and white papers for internal use
Oversee the synthesis and purification routine mRNA LNP products for preclinical studies
Establish and optimize the company\'s mRNA IVT manufacturing scale-up capability
Help develop scalable strategies for downstream product purification
Carry out process development studies using the design-of-experiments (DOE) approach
Oversee routine analytical and bioanalytical tasks such as HPLC, qPCR, ELISA, fragment analysis, cell-based assays, fluorescence, and flow cytometry
Coordinate in vivo studies in rodents for quality validation
Collaborate with the R&D teams and support experiments on Kernal Bio\'s R&D pipeline
Assist in I.P. filings and manuscript preparations
Select and manage CROs and CDMOs (with some travel if/when needed)
Oversee GMP manufacturing campaigns
Collaborate with academic partners for external preclinical studies
Prepare CMC sections for regulatory filings
Oversee COGS reduction strategy for in vivo CAR-T product
Present scientific findings internally and externally at critical scientific conferences and industry events
Analyze, summarize, and present experimental results to team members and management
Contribute to technical discussions and intellectual property related to Kernal\'s proprietary technologies
Explore new technologies and methods to optimize current processes in a fast-paced research environment
Maintain up-to-date records and communicate results to team members in written technical reports and oral presentations
Participate in experimental design and troubleshooting efforts
Interpret, summarize experimental data and maintain excellent laboratory notebooks
Requirements:
PhD/MS/BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or a similar field
10 years of industry experience in CMC field with 5 years of academic or industry experience in nucleic acid and/or lipid nanoparticle manufacturing
Attention to detail, ability to multi-task, and trouble-shoot
Strong written and verbal communication skills
Excellent record keeping and data management skills
The ideal candidate is adaptable, enthusiastic about new challenges, has an innate curiosity, and a passion for learning
Experience working in fast-paced startup environments
Excellent organization skills, approaching tasks with efficiency
Ability to analyze, summarize, and communicate scientific data
Ability to work independently while effectively interacting and collaborating in a team environment
Preferred: Experience with targeted lipid nanoparticles
Preferred: Experience with automation
Preferred: Prior mammalian cell culture experience
Preferred: Familiarity with nucleic acid purification and chemistry, enzyme kinetics, and analytical characterization of biomolecules
Preferred: Experience with analytical techniques HPLC/UPLC, FPLC, MALDI-TOF MS, LC-MS/MS, NMR
Preferred: Experience with bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools and GMP regulations
Nice to have: Prior in vivo experience with mice
Benefits
Competitive 401(k)
Highly competitive healthcare coverage (PPO/HMO)
Free parking, a monthly subway pass, or a subsidized commuter rail pass
Free Bluebike Membership
Gym Membership Support
Flexible Spending Account
Paid parental leave, family caregiver leave, and medical leave
Paid life insurance coverage
On-site cafeteria
Competitive vacation and sick days per year
Kernal provides a diverse work environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in employment practices for the race, color, national origin, age, gender, sexual orientation, marital or veteran status, religion, disability, or any other legally protected status. Kernal Bio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Seniority level : Executive
Employment type : Full-time
Job function : Management and Manufacturing
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About Kernal Biologics, Inc.
Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents. With support from leading investors, including Hummingbird Ventures, Amgen Ventures, Y Combinator, and HBM, Kernal Bio is transforming the future of cell therapy design and delivery. Job Summary Kernal Bio is seeking a highly motivated and experienced Vice President of Chemistry Manufacturing and Controls (VP of CMC) or Director of Process Development with expertise in mRNA manufacturing to contribute to the development of its mRNA 2.0 platform for therapeutic applications. The successful candidate will inspire and lead a team responsible for the manufacturing, process development, and analytical development of mRNA LNP therapeutics. Proficiency in mRNA LNP chemistry and biology workflows, coupled with experience in Good Manufacturing Practices (GMP) mRNA LNP manufacturing, is essential for this role.
Lead the CMC team and guide the company\'s drug substance and drug product manufacturing strategy
Work with senior management to expand the company\'s CMC team
Stay up-to-date on pertinent literature and prepare technical reports and white papers for internal use
Oversee the synthesis and purification routine mRNA LNP products for preclinical studies
Establish and optimize the company\'s mRNA IVT manufacturing scale-up capability
Help develop scalable strategies for downstream product purification
Carry out process development studies using the design-of-experiments (DOE) approach
Oversee routine analytical and bioanalytical tasks such as HPLC, qPCR, ELISA, fragment analysis, cell-based assays, fluorescence, and flow cytometry
Coordinate in vivo studies in rodents for quality validation
Collaborate with the R&D teams and support experiments on Kernal Bio\'s R&D pipeline
Assist in I.P. filings and manuscript preparations
Select and manage CROs and CDMOs (with some travel if/when needed)
Oversee GMP manufacturing campaigns
Collaborate with academic partners for external preclinical studies
Prepare CMC sections for regulatory filings
Oversee COGS reduction strategy for in vivo CAR-T product
Present scientific findings internally and externally at critical scientific conferences and industry events
Analyze, summarize, and present experimental results to team members and management
Contribute to technical discussions and intellectual property related to Kernal\'s proprietary technologies
Explore new technologies and methods to optimize current processes in a fast-paced research environment
Maintain up-to-date records and communicate results to team members in written technical reports and oral presentations
Participate in experimental design and troubleshooting efforts
Interpret, summarize experimental data and maintain excellent laboratory notebooks
Requirements:
PhD/MS/BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or a similar field
10 years of industry experience in CMC field with 5 years of academic or industry experience in nucleic acid and/or lipid nanoparticle manufacturing
Attention to detail, ability to multi-task, and trouble-shoot
Strong written and verbal communication skills
Excellent record keeping and data management skills
The ideal candidate is adaptable, enthusiastic about new challenges, has an innate curiosity, and a passion for learning
Experience working in fast-paced startup environments
Excellent organization skills, approaching tasks with efficiency
Ability to analyze, summarize, and communicate scientific data
Ability to work independently while effectively interacting and collaborating in a team environment
Preferred: Experience with targeted lipid nanoparticles
Preferred: Experience with automation
Preferred: Prior mammalian cell culture experience
Preferred: Familiarity with nucleic acid purification and chemistry, enzyme kinetics, and analytical characterization of biomolecules
Preferred: Experience with analytical techniques HPLC/UPLC, FPLC, MALDI-TOF MS, LC-MS/MS, NMR
Preferred: Experience with bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools and GMP regulations
Nice to have: Prior in vivo experience with mice
Benefits
Competitive 401(k)
Highly competitive healthcare coverage (PPO/HMO)
Free parking, a monthly subway pass, or a subsidized commuter rail pass
Free Bluebike Membership
Gym Membership Support
Flexible Spending Account
Paid parental leave, family caregiver leave, and medical leave
Paid life insurance coverage
On-site cafeteria
Competitive vacation and sick days per year
Kernal provides a diverse work environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in employment practices for the race, color, national origin, age, gender, sexual orientation, marital or veteran status, religion, disability, or any other legally protected status. Kernal Bio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Seniority level : Executive
Employment type : Full-time
Job function : Management and Manufacturing
#J-18808-Ljbffr