20 days old

Associate Director/Director Biologics Analytical Development & Formulation

BioReference Labs
Natick, MA 01760
  • Job Code
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 of Biologics Analytical Development and Formulations. The candidate will have hands-on experience in method development/validation, formulation development design and stability studies of Drug Substance (DS) and Drug Product (DP). The person will be accountable for design, execution and reporting of all analytical and formulation activities/data at external CDMOs and CROs. The position will report to Chief Technical Officer.

Key Responsibilities

  • Hands-on Leader and accountable Subject Matter Expert for all facets of characterization, release and stability testing of biologics.
  • Demonstrated experience in design and execution of Formulation development for biologics.
  • Ensure compliance of analytical testing activities with applicable compendia (EP, USP).
  • Contribute to and oversee the resolution of deviations, investigation, out-of-specification and out-of-trend results at CDMO/CRO.
  • Manage the development and supply of critical reagents and reference standard across testing sites.
  • Serve as primary author and reviewer of CMC sections related to analytical development, specifications, reference standard, comparability and stability in INDs and for regulatory correspondence.
  • Oversee manufacturability studies at CROs for selection of IND Drug Candidates.
  • Lead a Technical Development team for an IND/early-stage clinical program.
  • Develop seamless interface with in-house Antibody engineering and protein generation teams.
  • Work in concert with Process Development leader.
  • Serve as a member of ModeX CMC team participating in strategic planning, budget and long-range planning.

Requirement Knowledge, Skills, and Abilities
  • PhD. or M.S. in relevant biological/analytical field with 7 to 10 years of directly relevant industry experience.
  • Hands-on and demonstrated experience in analytical methods such as SEC, iCIEF, CE-SDS, SPR/OCTET/ELISA binding. Thorough understanding of data analysis and interpretation for biophysical methods such as DSC, DLS and AUC.
  • Must have designed the studies, compiled the results and personally authored the Elucidation of Structure section of a biologics IND.
  • Experience in leading analytical development teams at CDMO/CRO to deliver stage appropriate product control strategy.
  • Comprehensive working knowledge of cGMP and regulatory guidance as they relate to development, testing and shelf-life management of biologics products.

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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Sponsored by:
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Associate Director/Director Biologics Analytical Development & Formulation

BioReference Labs
Natick, MA 01760

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