Associate Manager, Quality Control
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.
The Associate Manager, Quality Control reports to the Vice President of Regulatory Affairs and is responsible for reviewing and maintaining quality documentation to support early and late-phase clinical development and commercial approval of drug products.
Key Responsibilities Include:
- Review data (test results, stability data, batch records, etc.) for product development and release to ensure compliance with analytical methods, specification criteria, and phase appropriate GMP
- Contribute analytical expertise to translate processes and methods to instructive procedures that ensure finished product quality
- Review and trend stability studies, analytical data, and processes as needed
- Coordinate with product development to translate research into verifiable processes to manage raw materials and finished product testing to ensure quality, product specifications and adherence to all current GMPs, USP, ICH and FDA guidance documents, local procedures and company Global standards
- Initiate, review and approve OOS and OOT investigations and deviations, following with CAPA as appropriate
- Prepare reports (testing and trending) for quality management review and annual product review as appropriate
- Contributes to GMP documentation including but not limited to master batch records, deviations, change controls, CAPAs, development reports, stability protocol/reports, and product specifications
- Supports QA Audits, clinical trial material release, and the preparation of M3 eCTD documents for global submissions
- Performs other duties as required
- BS Degree in scientific discipline required, Master’s Degree preferred
- 5 or more years’ experience in GXP environment and knowledge of GMP, GCP and GLP
- Understanding and experienced in application of phase-appropriate quality standards for manufacturing and clinical development programs
- Strong ability to investigate excursions to provide resolution with strong root cause analysis
- Proficient experience establishing Quality Systems/SOPs with Master Control
- Exceptional organizational skills with the ability to prioritize deadlines, maintain focus and monitor progress on assigned tasks, while working independently and collaborating in a team
- A creative, collaborative approach to problem solving
- Enjoys and thrives in a fast-paced and hands-on environment
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.
Apply for this position
Associate Manager, Quality Control