Process Development Chemist

Frequency Therapeutics (Nasdaq: FREQ) is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The company’s lead product candidate, FX-322, is a potential disease modifying therapy designed to regenerate damaged auditory hair cells to improve hearing function. In a Phase 1/2 study of FX-322, the company observed clinically meaningful improvement in key measures of hearing function in patients with sensorineural hearing loss, the most common form of hearing loss. A Phase 2a study is anticipated to begin in Q4 2019. The Frequency progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue and the company is researching an array of additional degenerative diseases where PCA may be applied, including a discovery program in multiple sclerosis.

Reporting to the VP Process and Medicinal Chemistry, we are seeking a Process Development Chemist who will lead and manage process chemistry synthesis for the company. They will be responsible for delivering multiple API’s, ensuring scaleups for pre-clinical studies and GMP synthesis are carried out effectively. Our ideal candidate will thrive in dynamic, start-up and early development environment and have a track record of success in leading and managing outsourced small-molecule programs.

Responsibilities Include:

  • Lead a team of chemists designing small-molecule process synthesis delivering bulk for pre-clinical studies, and GLP/GMP materials for clinical studies on aggressive timelines
  • Lead the scientific experimental design using QbD principles to develop efficient synthetic routes to APIs to support GLP/GMP manufacturing work supporting Pre-IND to Phase 3
  • Manage and collaborate with Contract Development and Manufacturing Organizations (CDMOs) to deliver GLP/GMP API for development
  • Coordinate meetings with CDMO’s to monitor progress, provide technical expertise, review reports and meeting minutes
  • Develop batch records and review with Quality Assurance personnel deviations and Corrective Action Preventive Action (CAPAs) to ensure GMP compliance
  • Manage drug substance-related documentation, batch records, development reports, and stability reports and develop internal SOP’s
  • Develop phase appropriate scalable synthetic routes appropriate for pharmaceutical development
  • In collaboration with analytical chemists identify, isolate, and synthesize impurities
  • Collaborate with quality assurance to ensure API deliverables meet all expected quality standards per appropriate guidance
  • When appropriate, source materials and ensure their timely delivery and quality
  • Author and review relevant GMP documentation and CMC-regulatory documents for regulatory filings and patent applications
  • Critically analyze experimental data, communicate results in the form of reports and presentations
  • Collaborate with the legal team in creating IP of new processes routes
  • Travel to CDMO sites domestically and internationally (10%)

Skills and Qualifications:

  • PhD in organic chemistry and at least 5 years of applicable pharmaceutical industry experience or a Master of Science degree with at least 10 years of applicable pharmaceutical industry experience
  • Familiarity with cGMP and ICH guidelines for drug substance
  • Experience managing external contract chemists and collaborating with multi-disciplinary teams to deliver clinical candidates
  • Experience with GMP synthesis
  • Proven track record of developing new process routes with innovative chemistry ideas and delivering multiple quality clinical candidate APIs on tight timelines
  • Self-starter that proactively anticipates needs and has ability to handle rapidly changing priorities and deliver on tight timelines with limited resources
  • Proven ability to work effectively with cross-functional teams in a matrix environment
  • Excellent verbal and written communication skills for effectively interfacing with vendors and internal stakeholders
  • Experience with technical report writing and a record of patents, publications and presentations

Corporate Culture:

A fundamental belief held by the Frequency Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large.

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Process Development Chemist

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