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Quality Control Associate

Company Overview

Spero Therapeutics is a global multi-asset clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts dedicated to developing a novel and highly differentiated pipeline of antibacterials focused on unmet needs of patients with drug resistant bacterial infections. Spero’s lead product candidate, SPR994, is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections. Spero also has a platform technology known as its Potentiator Platform that it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial infection, a rare and often chronic fatal infection. We are looking for highly motivated people who thrive on being challenged and working in a highly collaborative environment to join the team and play a key role in conducting rigorous, cutting-edge science.

Job Summary

We are seeking a Quality Control (QC) Associate to review chemical testing results of raw materials, intermediates, drug substance, drug product and reference standards for small-molecule manufacturing. Reporting to the Senior Manager of Quality Control, this position will operate within a virtual (100% outsourced) business model with direct communication with external Contract Manufacturing Organizations (CMO)/Contract Laboratory Organizations (CLO) QC laboratories. Cross-functional collaboration is critical to this role. This is not a lab based position.

Responsibilities

  • Evaluate data to ensure compliance with analytical methods, specifications and GMPs
  • Support of QC and analytical testing activities at CMOs/CLOs: perform review of in-process, release and stability data for small molecule products under cGMP
  • Review/approve technical reports, controlled GMP documents (e.g., analytical methods and associated validation documents, specifications, change controls, LIRs, SOPs, etc.).
  • Member of a cross functional CMC team to support manufacturing and process development of small molecule drug candidates
  • Contribute QC expertise to process development and manufacturing of regulatory starting materials, drug substance and drug products (oral and parenteral)
  • Review and trending of stability studies and data analysis
  • Communicate effectively in verbal and written form; prepare high quality written documentation and assists in regulatory documentation (INDs/IMPDs/NDAs)
  • Develop and maintain strong relationships with CMO business partners.

Qualifications and Experience

  • A B.S./M.S. degree in analytical chemistry or related life sciences discipline
  • 3-5 years of experience in the pharmaceutical industry
  • Experience and in depth understanding of routine instrumental methods: HPLC, GC, Mass Spec., Dissolution, UV, etc
  • Familiarity with following Standard Operating Procedures (SOPs), application of cGMPs, FDA regulations and ICH Guidelines required
  • Experience performing GMP review of raw data and analytical reports
  • Requires strong attention to details, written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally
  • Ability to work successfully in a team/matrix environment and independently, as required.
  • Advanced problem-solving skills, the ability to think strategically and have sound scientific judgement
  • Limited travel: <10% (nationally and potentially internationally)

 

Spero Therapeutics 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/vision plans, 401(k) match retirement plan, incentive stock options, 4 weeks paid time off, professional development, and frequent social opportunities.

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