Senior/Principal Process Development Scientist

The incumbent will be responsible for the development and execution of robust, well understood process and timely manufacture of cGMP materials.  This will involve the rapid design of syntheses and isolations, in conjunction with the identification of key process parameters, the origin of impurities and the appropriate process controls.  The ideal candidate will support API registration and validation for our lead program SPR994 and lead early clinical candidates through process development and clinical manufacturing.

Responsibilities

  • Responsible for process development and manufacture of drug substances under cGMP conditions at external CMO
  • Interpret raw data, organize results, generate/review reports, and communicate findings to scientific teams and upper management
  • Responsible for vendor management, including new vendor operational due diligence, technology transfer and cGMP manufacturing productions
  • Manage process development teams (internal and external) that develop new and/or enhance existing processes
  • Oversight of CDMOs and the corresponding SOWs
  • CMC subject matter expert (SME) of relevant regulatory submissions
  • Will represent CMC and development in internal and external cross-functional program teams
  • Collaborate with Formulation Development and Analytical Development to define and execute development strategies that enable phase appropriate deliverables
  • Effectively summarize key information such as program progress, timeline updates, budgetary impact, and risk/opportunity assessments for periodic presentation to CMC group and management
  • Conduct scenario planning to proactively provide analysis and recommendations on alternative development plans, along with associated assumptions and risks
  • Investigate, identify root cause, and approve CAPA for manufacturing deviations
  • Assist in the review and evaluation of CMC documents during due diligence exercise, and source documents for regulatory filings

Qualifications and Experience

  • Masters’ degree in organic chemistry 5-10 years in pharmaceutical process chemistry and GMP development
  • D. and 2-5 years in pharmaceutical process chemistry and GMP development
  • Strong knowledge of modern synthetic organic chemistry and drug development processes
  • Registration and Validation experience a plus
  • Experience in cGMP manufacturing and in supporting regulatory submissions
  • Good interpersonal and organizational skills with demonstrated ability effectively to manage multiple projects
  • Demonstrated ability to work well in interdisciplinary team
  • Strong critical thinking and problem solving skills
  • The ability to perform under pressure, manage outsourced projects with external vendors, and work effectively in a fast pace environment
  • Working knowledge of regulatory guidelines
  • Travel globally for up to 20% of the time

Spero has a vibrant and engaging culture of innovation and team work and we are continuing to build a top-tier team to rapidly advance our programs in a fast-paced, exciting and fun work environment. We offer a robust benefits package including premium health/dental plans, 401(k) retirement plan, incentive stock options, 4 weeks paid time off, professional development, and frequent social opportunities.

Please forward your CV/resume to Careers@sperotherapeutics.com

Spero Therapeutics, Inc. 675 Massachusetts Avenue, 14th Floor, Cambridge, MA 02139

www.sperotherapeutics.com