19 days old

Associate Director/Director Drug Substance Process Development & Manufacturing

BioReference Labs
Natick, MA 01760
  • Job Code
    OPK-22-14017
This 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.

We are looking for talented, collaborative, experienced Associate Director/Director Drug Substance Process Development & Manufacturing for ModeX programs being executed at Contract Development and Manufacturing Organizations (CDMO). The candidate will have hands-on experience in Antibody Drug Substance Process Development (PD) and Manufacturing. Experience covering both Upstream and Downstream PD is required. The position will report to Chief Technical Officer.

Key Responsibilities

  • Hands-on Leader and accountable Subject Matter Expert for CDMO selection and outsourcing for PD from cell line generation to Drug Substance supply.
  • Lead and oversee CDMOs, ensuring design, execution, analysis and documentation of development experiments is scientifically robust.
  • Provide leadership to CDMO project teams and monitor technical quality of all PD work done and documents generated.
  • Deliver robust, scalable and user-friendly GMP operations.
  • Develop seamless interface with in-house Antibody engineering and protein generation teams.
  • Work in concert with Analytical Development and Formulation leader.
  • Serve as a member of ModeX CMC team participating in strategic planning, budget and long-range planning.

Requirement Knowledge, Skills, and Abilities
  • or M.S. in biotechnology, bioengineering or chemical engineering with 7 to 10 years of directly relevant experience.
  • Hands-on and demonstrated experience in cell line development, cell culture process development, harvest technologies, bioreactor process scale up, downstream purification development, column chromatography principles, viral clearance study and generation of master batch records.
  • Proven track record of developing and optimizing processes for the manufacturing of biologics products including yield, quality, cost of goods reduction and scale-up and scale-down models.
  • Experience in authoring and reviewing CMC sections for IND filings and responding to regulatory inquiries and questions.
  • Attention to details and careful record keeping.

ModeX Therapeutics is developing the next generation of higher order multi-specific antibodies as novel therapies in multiple disease areas enabled by our proprietary platform technologies. Our strategic focus is to develophighly flexible multi-specific antibody technology platforms with broad targeting and functional capabilities, and potentially better specificity and safety, providing significant differentiation from competing platforms. In addition, the design of ModeX multi-specific antibodies is also amenable to gene-based delivery by mRNA or DNA vectors.

ModeX Therapeutics, Inc is an Equal Opportunity Employer





Posted: 2022-09-09 Expires: 2022-10-08
Sponsored by:
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Associate Director/Director Drug Substance Process Development & Manufacturing

BioReference Labs
Natick, MA 01760

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