Associate Director, Analytical Development
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 Director, Analytical Development, reports to the Senior Director, Pharmaceutical Development. The successful candidate will be part of a team contributing to the development of the company’s PCA technology platform and executing the company’s small-molecule combination strategy in a cross-functional team environment. This role requires experience and expertise working with external partners to execute project goals as well as some hands-on laboratory work. The Associate Director’s laboratory expertise will be pivotal in the successful development of pharmaceutical products based on the company’s PCA platform.
- Interface with external CDMOs and other corporate partners to develop and review analytical methods, help set product specifications, review externally developed data and methods, etc.
- Developing robust and phase-appropriate analytical methods, such as assay and impurity, to support corporate research and development objectives
- Working with other project scientists in preparation of work plans and the analysis of samples using high-pressure liquid chromatography (HPLC) and other analytical instrumentation
- Processing and interpreting analytical data and results, and maintenance of an electronic lab notebook (ELN)
- Communication and presentation of data in a cross-functional setting
- Writing SOPs, development reports, protocols, batch records, etc.
- Troubleshooting and maintenance of analytical laboratory equipment
- Mentor, train and direct project tasks of junior scientists on execution of analytical methods
- PhD in in Biology, Chemistry, Pharmaceutics, Physics or related field of study with 9 or more years post-graduate experience in an academic laboratory focused on Analytical Method development
- Experience coordinating project work with external contract laboratories and/or product development partners
- Experience with liquid chromatography is mandatory. Knowledge of different types of chromatographic separation and experience with various detectors (UV, MS, RID, CAD, MALS, etc.) is desired
- Experience with dissolution and other instrumentation for drug substance and drug product characterization is a plus
- Familiarity and experience with ICH guidance on Analytical Method Development and Validation, i.e. ICH Q2(R1), is desirable
- Ability to proficiently design and execute experiments in a detail-oriented manner
- Enthusiastic learner willing to learn and operate various analytical instruments as required
- Problem-solving and troubleshooting skills
- Flexibility, ability and commitment to manage multiple competing priorities while meeting expected deadlines; willing to take initiative in pursuit of project and team goals
- Ability to work both independently and in a team-based environment as needed
- Strong written and verbal communication skills
- Experience using software packages such as LIMS, ELN, Chemstation, Microsoft Office, etc. is preferred
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. Please visit www.frequencytx.com for more information.
We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology.
Frequency Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.