Address
Form of workThis is an exciting time to join our cutting-edge organization! ModeX Therapeutics, an OPKO Health company, is developing the next generation of multi-specific antibodies as novel therapies for cancer and infectious diseases, as well as nanoparticle technologies for the development of next generation vaccines. Join our team of groundbreaking scientists today and change the world tomorrow.
ModeX Therapeutics, an OPKO Health subsidiary, is a clinical-stage biopharmaceutical company developing next-generation multispecific antibodies and vaccines for cancer and infectious disease. ModeX's modular antibody platforms unite the power of multiple biologic components in a single molecule to create multispecific antibodies with greater versatility and potency to fight complex disease than traditional approaches. Our pipeline includes candidates against both solid and hematological tumors as well as several of the world's most pressing viral threats. Our founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients.
Job Summary:
The incumbent will play a key role in advancing ModeX targeted nucleotide delivery platform from preclinical stage to early phase clinical trials. This position requires a solid scientific background and a track record of working with CDMOs to achieve CMC objectives and deliver on project milestones. The successful candidate will be responsible for mRNA process development and manufacturing, acting as SME and overseeing all mRNA CMC Drug Substance activities, from sequence through Drug Substance release.
Key Responsibilities:
- Lead all activities related to delivering high-quality mRNA Drug Substance at CDMOs.
- pDNA vector and sequence development to optimize mRNA Drug Substance yield.
- Strain development, cell banking, and manufacturing of pDNA starting material.
- mRNA IVT reaction and downstream process development to optimize yield and product quality attributes.
- Scale-up and cGMP manufacturing of mRNA Drug Substance, including identification, management, supply, and control of suitable raw materials to obtain high-quality mRNA.
- Cultivate CDMO relationships for on-time delivery of CMC work packages that adhere to current regulatory and cGMP guidelines.
- Interpret and present data and progress to senior leadership and external stakeholders.
- Author and/or review relevant sections of pre-IND and IND/IMPD submissions.
Qualifications:
- Ph.D. in a relevant engineering or science field.
- Minimum 8+ years of experience in the biopharmaceutical industry, or equivalent.
- mRNA Drug Substance process development and cGMP manufacturing leveraging CDMOs.
- IVT reaction design, RM selection, and control strategy to optimize titer and product quality.
- Downstream processing of nucleotides and proteins.
- Good understanding/knowledge of the overall drug development process, cGMPs, and regulatory requirements.
About ModeX Therapeutics
ModeX is a clinical-stage biopharmaceutical company developing next-generation antibodies and vaccines for cancer and infectious disease. ModeX's modular antibody platforms unite the power of multiple biologic components in a single molecule to create multispecific antibodies with greater versatility and potency to fight complex disease than traditional approaches. Our pipeline includes candidates against both solid and liquid tumors as well as several of the world’s most pressing viral threats. Our founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is an OPKO Health Company based in Weston, Massachusetts. For more information see modextx.com.
ModeX Therapeutics is an Equal Opportunity Employer
