Senior Scientist I, 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 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.
The Senior Scientist I, Analytical Development, is a laboratory-based position and reports to the Director, Analytical 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. The Scientist’s laboratory expertise will be pivotal in the successful development of pharmaceutical products based on the company’s PCA platform. This position is a laboratory-based role with tremendous learning potential.
Key responsibilities include:
- 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.
- Interfacing with external CDMOs, CROs, etc., as needed to support method transfer activities
- Troubleshooting and maintenance of analytical laboratory equipment
- Mentor and train junior scientists on execution of analytical methods
- PhD in Chemistry, Biology, Pharmaceutics, Engineering or related field of study with at least 4 years post-graduate experience in an academic or an industry laboratory focused on Analytical Method development
- MS/BS in Chemistry, Biology, Pharmaceutics, Engineering or related field of study with at least 8 years of experience in an industrial laboratory focused on Analytical Method development will also be considered
- 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, gas chromatography, Karl Fischer and other instrumentation for drug substance and drug product characterization is a plus
- Experience with structure elucidation and trace analysis of impurities using LC/MS or LC/MS/MS is a plus
- Experience with solid state characterization methods, such as DSC, TGA, PSD and XRPD etc. 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
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.