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Director of Downstream Process Development

1 month ago

Boston, Massachusetts, United States EPM Scientific Full time
Job Description

As a key member of our team, the Director of Downstream Process Development will be responsible for leading the development and optimization of downstream processes for the production of novel biologics. This role requires a strong understanding of chromatography, filtration, and process validation, as well as a strategic vision for developing innovative solutions in downstream processing.

Key Responsibilities:

  • Develop and implement downstream process development strategies to ensure compliance with regulatory guidelines and project timelines.
  • Lead cross-functional teams to design, develop, and optimize downstream processes, including purification methods like chromatography, filtration, and ultrafiltration/diafiltration.
  • Drive process characterization and validation in accordance with regulatory guidelines (FDA, EMA, ICH).
  • Perform CMC risk assessment activities in a phase-appropriate manner to ensure proper measures are in place in support of production and filing requirements.
  • Collaborate with quality assurance, regulatory affairs, and manufacturing teams to ensure seamless integration and process success.

Qualifications & Requirements:

  • Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with years of experience in downstream process development; with at least 5 years in a leadership role within the biopharmaceutical industry.
  • Strong expertise in the purification of biologics, including monoclonal antibodies, proteins, viral vectors, or similar biologics.
  • Experience with scale-up and technology transfer to GMP manufacturing.
  • Extensive knowledge of downstream purification techniques (e.g., chromatography, filtration) and associated analytical methods.
  • Proven track record in process characterization, validation, and regulatory submissions.
  • Familiarity with automated process development tools and high-throughput screening technologies.
  • Experience working with CDMOs and external manufacturing partners.