Spero Therapeutics Senior Scientist, Process Development in Cambridge, Massachusetts
Spero Therapeutics (Nasdaq: SPRO) is a multi-asset pre-commercial stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotechnological and biopharmaceutical experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on patients' unmet needs with multi-drug resistant (MDR) bacterial infections. Spero’s lead product candidate, tebipenem HBr, is an oral carbapenem being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP. Spero is also developing SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero’s third product candidate, SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections.
We believe that our novel product candidates will have a meaningful impact on patient health and significant commercial applications for treating MDR infections in hospitals and community settings.
General Scope and Summary of Role
Spero Therapeutics is seeking a highly motivated, experienced Process Development Senior Scientist to join the CMC team. The incumbent will be responsible for the development and execution of robust, well-understood processes and timely manufacture of cGMP materials at external CDMOs. 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 immediate focus will be to support API validation and commercialization for our lead program SPR994.
What You’ll Do
Responsible for process development and manufacture of drug substances under cGMP conditions at external CDMOs
Interpret raw data, organize results, generate/review reports, and communicate findings to scientific teams and upper management
Responsible for vendor management, technology transfer and cGMP manufacturing productions
Construct and review batch records
Provide on-site support for production at CMO facilities
Investigate, identify root cause, and support CAPA for manufacturing deviations
Collaborate with Formulation Development and Analytical Development to define and execute development strategies that enable phase appropriate deliverables
Conduct scenario planning to proactively provide analysis and recommendations on alternative development plans, along with associated assumptions and risks
Assist in preparing CMC documents and source documents for regulatory filings
What You’ll Need
PhD with 3+ years or MS degree in chemistry or chemical engineering with 10 years in pharmaceutical process chemistry and GMP production
Strong knowledge of synthetic organic chemistry and drug development processes; experience with peptide is a plus
Understands quality assurance and quality control requirements of cGMP production
Working knowledge of regulatory guidelines; Registration and Validation experience is a plus
Demonstrated ability to work well in interdisciplinary, fast pace environment
Strong critical thinking, problem solving and technical writing skills
Ability to manage outsourced projects
Travel globally up to 20% of the time
By joining our committed and highly motivated team, you’ll experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero’s culture is one that emphasizes “servant leadership,” or putting ego aside and working for the benefit of the team and our patients, and values our colleagues’ opinions and celebrates accomplishments in service of patients.
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