Senior Process Development Engineer/Scientist
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 Process Development Engineer/Scientist, reports to the VP, Pharmaceutical Development, and will have a leading role in the development of our lead clinical product, FX-322. The Senior Process Development Engineer/Scientist’s expertise in process optimization, scale up, and lyophilization will be pivotal in the successful development of pharmaceutical FX-322 and other products based on the company’s PCA platform.
Key Responsibilities Include:
- Lead the scale-up activities for Frequency’s lyophilized product, FX-322.
- Carry out clinical 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.
- Use QbD principals in drug product development including the establishment of stability indicating criteria, drug release profiles, drug product impurity profiles, fate of impurities, product performance criteria, critical quality attributes, etc.
- Identify, vet, select third-party contractors and execute project objectives through these contractors. This includes selecting contractors with the appropriate technical capabilities and quality standards, establish and maintain good relationships, and represent Frequency in the best possible manner.
- Serve as a primary product development liaison with internal team members and collaborations
- 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
- Establish and build relationships with external CMC thought leaders and consultants
- Ensure that GMP clinical supplies are manufactured, assayed, shipped, and stored in accordance and compliance with appropriate regulatory procedures
- Support the preparation for commercial launch of the company’s products.
- PhD in Pharmaceutics or Chemistry, or related fields; and 9+ years of industry experience. OR a BS in Chemical Engineering or Bioengineering and 10+ years of industry experience
- Demonstrated extensive experience in lyophilization, formulation manufacturing process development, analytical techniques, experimental design, and other CMC related activities.
- Knowledge of the requirements for drug product scale-up and manufacture and experience supporting these activities. Specific experience in lyophilization is required.
- 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 record of demonstrating the application of process development techniques to overcome manufacturing challenges leading to successful drug products.
- Experience identifying, evaluating, selecting third-party contractors and executing project objectives through these contractors.
- 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 Process Development Engineer/Scientist