Senior Scientist II, Formulations
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 Senior Scientist II, reports to the VP, Pharmaceutical Development, and will have a leading role in continuing to develop the company’s PCA technology platform and executing the company’s small-molecule combination strategy in a cross-functional team environment. The Scientist’s expertise in drug delivery, formulation development, and drug product manufacturing will be pivotal in the successful development of pharmaceutical products based on the company’s PCA platform.
Key Responsibilities Include:
For prototype drug formulations selected for further development:
- Design and carry out experiments to determine “developability” of prototype formulations.
- Pre-formulation and formulation development using various formulation platforms to be administered by the appropriate route for the drug product such as parenteral, oral, transdermal, etc.
- Formulation feasibility studies
- Use QbD principals in formulation development.
- Establish stability indicating criteria, release profiles, impurity profiles, etc.
- Carry out formulation development activities which include: process optimization studies, prepare pilot batch documentation, ensure availability of raw materials, oversee pilot batch manufacture, and complete batch documentation as required.
- Optimization of formulations to provide desired formulation performance according to product requirements. These may include dissolution, duration of drug release, stability in situ, transmembrane delivery, and others as required.
- Serve as primary formulation liaison with internal team members and be able to clearly explain the purpose of experiments and experimental results to senior management and non-scientists within the company.
- Assist in the preparation of CMC sections of regulatory filings, technical and verbal reports and presentations on project progress as well as specifications, procedures, and SOPs
- Coordinate with Analytical Services, Manufacturing, QC, QA and other groups and activities as necessary to ensure project requirements are met.
- Coordinate work with 3rd party external partners to develop experimental work plans and ensure that the desired work is completed on time and within budget.
- Guide and assist in the training, development and evaluation of any personnel whose work he/she directs.
- Assist in maintaining a high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position.
- Perform miscellaneous technical and administrative duties as required to meet company objectives.
- PhD in Pharmaceutics or Chemistry, or related fields; and 7+ years of industry experience in pharmaceutical product development.
- Demonstrated extensive experience in analytical techniques, formulation development in multiple formulation platforms, formulation manufacturing process development and other CMC related activities. Experience with lyophilization and lyophilized products is a must.
- A thorough knowledge of the drug development process, including the understanding of appropriate tasks for each phase of development, familiarity with appropriate regulatory and quality guidelines, writing regulatory submissions, etc.
- A demonstrated understanding of how FDA and ICH quality guidelines and expectations are applied in each phase of drug development.
- Proven ability to interpret experimental results to form appropriate recommendations and provide guidance on next experiments; prioritize tasks to align with company strategy
- Knowledge of the requirements for drug product scale-up and manufacture and experience supporting these activities. Specific experience in lyophilization is required.
- Proven record of demonstrating the application of process development techniques to overcome manufacturing challenges leading to successful drug products.
- Strong interpersonal, communication, and project management skills with the ability to interact effectively with a variety of personnel including medical, regulatory, quality, finance, and manufacturing staff.
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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Senior Scientist II, Formulations