Kernal Biologics · 2 days ago
Vice President of Chemistry Manufacturing and Controls (VP of CMC)
Boston, MA
Full-time
Onsite
Director/Executive
10+ years expKernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. The Vice President of Chemistry Manufacturing and Controls (VP of CMC) will lead the CMC team in the manufacturing and process development of mRNA LNP therapeutics, ensuring compliance with Good Manufacturing Practices (GMP).
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
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 & intellectual property related to the development and application of 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
Qualification
Required
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
Experience with automation
Prior mammalian cell culture experience
Familiarity with nucleic acid purification and chemistry, enzyme kinetics, and analytical characterization of biomolecules
Experience with analytical techniques HPLC/UPLC, FPLC, MALDI-TOF MS, LC-MS/MS, NMR
Experience with bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools and GMP regulations
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
Company
Kernal Biologics
Kernalbio creates mRNA therapies that instruct specific cells on how to make their own medicine.
11-50 employees
H1B Sponsorship
Kernal Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2021 (1)
Funding
Current Stage
Early StageTotal Funding
$73MKey Investors
Advanced Research Projects Agency for HealthHummingbird Ventures
2025-10-07Grant· $48M
2022-07-07Series A· $25M
2020-10-21Seed
Leadership Team
B
Burak Yilmaz
Founder & President
Recent News
Google Patent
2025-02-08
Company data provided by crunchbase