Director/Associate Director, Process Chemistry
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 initial clinical studies of FX-322, the company observed meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss, the most common form of hearing loss which impacts more than 90 percent of all people with hearing loss. The company recently completed enrollment of a Phase 2a study, with results to be shared in Q2 2021. Frequency’s 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 pre-clinical program for remyelination in multiple sclerosis.
Reporting to the VP, Process and Medicinal Chemistry, we are seeking a Director / Associate Director, Process Chemistry who will lead and manage process chemistry synthesis for the company. They will be responsible for delivering API’s, ensuring scale-ups for pre-clinical studies and GMP synthesis are carried out effectively. Our ideal candidate will thrive in a dynamic, start-up and early development environment, and have a track record of success in leading and managing outsourced small-molecule programs.
Key Responsibilities Include
- Lead a team of external chemists designing small-molecule process synthesis delivering bulk for pre-clinical studies, and GLP/GMP materials for clinical studies on aggressive timelines
- Develop phase appropriate scalable synthetic routes appropriate for pharmaceutical development
- 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) and strategic partners to deliver GLP/GMP API for development
- Coordinate meetings with CDMO’s to monitor progress, provide technical expertise, and review reports
- Review batch records with Quality Assurance personnel, identifying deviations and taking 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
- 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
- Contribute to relevant GMP documentation and CMC-regulatory documents for regulatory filings
- Critically analyze experimental data, communicate results in the form of reports and presentations
- Collaborate with the legal team in creating IP
- Travel to CDMO sites domestically and internationally (as appropriate)
- 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 chemistry 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 of delivering multiple quality clinical candidate APIs on tight timelines
- Self-starter that proactively anticipates needs and develops solutions to deliver API on time
- Proven ability to work effectively with cross-functional teams in a matrix environment
- Excellent verbal and written communication skills for effectively interfacing with vendors, strategic partners, and internal stakeholders
- Experience with technical report writing and a record of patents, publications and presentations.
Working at Frequency
At Frequency Therapeutics, we believe that we have the best chance to achieve our mission by creating an environment where our collective problem-solving and leadership skills are put to work, so collaboratively, we can solve some of the most complex challenges in medicine. We are focused on developing new treatments to potentially help millions of patients with novel therapeutics. This requires both a willingness to be audacious in our pursuits and relentless in our focus and commitment to research and patients. We look for individuals who are both highly skilled and self-aware, who are willing to challenge leadership and their colleagues, are entrepreneurial by nature and who are undeterred by uncertainty.
Please visit www.frequencytx.comfor more information.
We offer a competitive compensation and benefit package. For consideration, please submit CV and cover letter.