Current jobs related to Director/Assoc. Director of Process Development - Boston, Massachusetts - Kernal Biologics

  • Director of Downstream Process Development CMC

    2 hours ago

    Boston, Massachusetts, United States EPM Scientific Full time

    Director, Downstream Process DevelopmentLocation:Greater Boston AreaPosition Summary:Currently partnered with a leading clinical-stage biotech that is developing several first-in-class traditional biologics across multiple stage development. They are looking to bring on an experienced Director of Downstream Process Development to spearhead their late-stage...

  • Associate Director of Development

    5 hours ago

    Boston, Massachusetts, United States Temple Israel of Boston Full time

    OverviewThe Associate Director of Development is a new role that strengthens Temple Israel's capacity to sustain and grow our Friends Annual Fund and related philanthropic initiatives. Temple Israel is currently in the leadership phase of a comprehensive campaign expected to span the next two years, and this position will play a key supporting role in that...

  • associate director of development

    2 hours ago

    Boston, Massachusetts, United States Temple Israel of Boston Full time

    Temple Israel of Boston is widely recognized as the largest Reform temple in New England, and it is one of the most prominent synagogues in the greater Boston area. At Temple Israel, our mission of "Living Judaism Together" means that we acknowledge, welcome, and honor each individual in our community for who they are. Temple Israel is known for offering an...

  • Director of Development

    4 hours ago

    Boston, Massachusetts, United States Biomedical Science Careers Program (BSCP) Full time

    ABOUT THE ORGANIZATIONThe Biomedical Science Careers Program (BSCP) exists to ensure people of every race, ethnicity, gender, and financial background are represented in science and medicine, while also enabling science-related industries and institutions to build a more inclusive workforce. For many students today, a future in science or medicine is nothing...

  • Director, Analytical Development

    3 hours ago

    Boston, Massachusetts, United States Olema Oncology Full time

    Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product...

  • Director - Solution & Process Governance

    5 hours ago

    Boston, Massachusetts, United States Avangrid Full time

    Job Title: Director – Solution and Process GovernanceReports to: Sr Manager - Digital Strategy & Cust ExpReports in office to Boston, MAThe base salary range for this position is dependent upon experience and location, ranging from: $167,428.-$209,286Job SummaryThe Director Solution and Process Governance is a key member of Avangrid's Customer Experience...

  • Director, Corporate Development

    2 hours ago

    Boston, Massachusetts, United States Fidelity Investments Full time

    Job DescriptionDirector, Corporate DevelopmentThe RoleReporting to the Senior Vice President, Corporate Development, the Director will support the Corporate Development team and business partners in the valuation and due diligence process of potential acquisitions and strategic investments including the coordination of due diligence activities with internal...

  • Director of Biologics Drug Substance Development

    2 hours ago

    Boston, Massachusetts, United States AVEO Oncology Full time

    JOB TITLE: Director of Biologics Drug Substance Development & ManufacturingDEPARTMENT: Technical Operations, BiologicsREPORTS TO: Sr. Director Biologics TechnicalDATE PREPARED: November 7, 2025SUMMARY:AVEO is seeking a Director of BDS Development who will lead all work associated with developing manufacturing processes and manufacturing BDS for clinical...

  • Deputy Director

    5 days ago

    Boston, Massachusetts, United States City of Boston Full time

    OverviewThis strategic, innovative, collaborative, and forward-thinking individual will be primarily responsible for supporting the Director in all aspects of the department's human resources, including staff recruitment, retention, hiring, onboarding, performance management, and payroll. The Deputy Director of Human Resources will also support and lead...

  • Business Development Project Director

    3 hours ago

    Boston, Massachusetts, United States Cogent Talent Solutions Full time

    Business Development Project DirectorThis is a Subject Matter Expert (SME) role in Sales and Business Development. Build, implement, train, and evaluate customized business development solutions that support a lead Project Director and an Engagement plan, assisting small to medium-sized businesses (SMBs) in achieving their strategic objectives. Solution...

Director/Assoc. Director of Process Development

11 hours ago

Boston, Massachusetts, United States Kernal Biologics Full time

Director/Assoc. Director of Process Development

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 Director/Associate 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 process development of mRNA-targeted LNP therapeutics. Proficiency in mRNA-tLNP chemistry, analytics, and biology workflows, coupled with experience in antibody-decorated lipid nanoparticle scale-up is essential for this role.

Responsibilities:

  • Lead the process development team and guide the company's drug substance and drug product process development.
  • 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, purification, and formulation of routine mRNA-tLNP products for preclinical studies
  • Establish and optimize the company's mRNA-tLNP manufacturing scale-up capability 
  • Help develop scalable strategies for downstream product purification 
  • Conduct process development studies using the design of experiments (DOE) approach.
  • Help with 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 process quality validation 
  • Collaborate with the R&D teams and support experiments on Kernal Bio's R&D pipeline
  • Assist in IP filings and manuscript preparations
  • Select and manage CROs and CDMOs (with some travel if/when needed).
  • Finalize and transfer the process for IND enabling studies and GMP manufacturing campaigns
  • Collaborate with academic partners for external preclinical studies
  • Prepare CMC sections for regulatory filings
  • Oversee the 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

Requirements:

  • PhD/MS/BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or a similar field
  • 8 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

Benefits:

  • Competitive 401(k)   
  • Highly competitive healthcare coverage (PPO/HMO)
  • Free parking, monthly subway pass, or a subsidized commuter rail pass  
  • Free Bluebike Membership
  • Gym Membership Support   
  • Flexible Spending Account 
  • Paid parental leave, family caregiver leave, 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.