Director Drug Substance, Oligonucleotide, Remote - Fort Lauderdale - Syncromune

    Syncromune
    Syncromune Fort Lauderdale

    10 hours ago

    Description

    The Director of Oligonucleotide Drug Substance Development and Manufacturing will lead and manage the development and manufacture of oligonucleotide drug substances across the product lifecycle with a focus on technology transfer scale-up process characterization and process validation at external Contract Development and Manufacturing Organizations CDMOs.

    This role requires close collaboration with internal cross-functional teams and external partners to ensure the successful development regulatory submission and commercialization of therapeutic products.

    Key Responsibilities

    • Process Development Lead the development optimization of scalable robust manufacturing processes for oligonucleotide drug substances ensuring efficiency yield purity and product quality.
    • Apply principles of physical chemistry process engineering analytical chemistry to design control manufacturing processes that result in high purity drug substance.
    • Implement Quality by Design QbD principles ensuring compliance with current Good Manufacturing Practices cGMP partner closely with Quality to adhere applicable GxP requirements prepare technical reports author review approve relevant sections INDs NDAs/BLAs briefing packages submissions develop timelines budgets support clinical supply registration milestones participate technology transfer activities lead knowledge transfer smooth execution plan oversee scale-up activities support clinical registration commercial needs define risk-based strategies based on product lifecycle stage process complexity CDMO capabilities execute characterize studies including DoE approaches identify critical parameters establish control strategies oversee early GMP late-stage manufacturing characterizing clinical lots collaborate Analytical Development Manufacturing QA Regulatory Affairs Clinical Development Program Management as well as external partners manage multiple programs contribute project prioritization timelines budget Control oversight sample handling testing release stability trending investigate Cerificates Analysis materials enable timely supply meet trials demands monitor retesting expiration extension generate raw specifications protocols maintain inventory organize database updating direct internal manufacture technologies raw material specifications directly interact reporting fraud escalation . Success measurable skillset demonstrated case deployed extensive activity variety validate consultancy companies apply consultations tasks leading owned team international.
  • Work in company

    Director Drug Substance, Oligonucleotide, Remote

    Only for registered members

    · The Director of Oligonucleotide Drug Substance Development and Manufacturing will lead and manage the development and manufacture of oligonucleotide drug substances across the product lifecycle, with a focus on technology transfer, scale-up, process characterization, and proce ...

    Remote

    4 days ago

  • Work in company

    Director Drug Substance, Oligonucleotide

    Only for registered members

    The Director of Oligonucleotide Drug Substance Development and Manufacturing will lead development and manufacture of oligonucleotide drug substances. · ...

    Fort Lauderdale $235,000 - $255,000 (USD)

    2 weeks ago

  • Work in company Remote job

    Director Drug Substance, Oligonucleotide

    Only for registered members

    The Director of Oligonucleotide Drug Substance Development and Manufacturing will lead and manage the development and manufacture of oligonucleotide drug substances across the product lifecycle, with a focus on technology transfer, scale-up, process characterization, and process ...

    Fort Lauderdale, FL

    2 weeks ago

  • The Director of Oligonucleotide Drug Substance Development and Manufacturing will lead and manage the development and manufacture of oligonucleotide drug substances across the product lifecycle. · Master's or Ph.D. degree in Pharmaceutical Sciences, Chemical Engineering, Biochemi ...

    Fort Lauderdale, FL

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    Only for registered members

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