Senior CMC Operations And Stability Specialist

Senior CMC Operations And Stability Specialist

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington's disease, as well as a preclinical program in obesity. Driven by the calling to "Reimagine Possible", we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Wave seeks a highly motivated Senior CMC Operations and Stability Specialist to join the CMC group. The Senior CMC Operations and Stability Specialist is responsible for managing CMC-related compliance activities through all phases of development (pre-clinical, Phase I-III) for multiple programs, including technical writing. This role is a newly created position within Wave, a company committed to getting meaningful therapies to patients. The position works with multiple functional groups such as, AD/QC (Analytical Development/Quality Control), MS&T (Manufacturing, Science, and Technologies), PD (Process Development), DPTS (Drug Product Technical Services), Regulatory CMC, and QA (Quality Assurance) representatives to drive CMC activities through development and ensure compliance with internal and external requirements.

The successful candidate is self-motivated, independent, highly organized, and able to work in a small team environment. This is an ideal position for an individual who is interested in learning cutting edge technologies including first-in-class RNA editing therapeutic platform (under collaboration with GSK) and who thrives in a team-oriented, fast-paced, and cross-disciplinary biotech environment. This position is hybrid, you will be expected to work on site at our Lexington, MA facility.

Experience:

• BS, MS, and/or PhD in related field
• Minimum 5 years of experience in Pharmaceutical Industry in a CMC-related role such as stability, analytical development, regulatory, quality assurance, etc.
• Knowledge of FDA and international regulations and GxP guidelines

Responsibilities:

• Own and manage change controls, deviations, CAPAs related to CMC operations/stability
• Review, manage, and drive approval of technical protocols and reports to support CMC activities from cross-functional areas
• Review/author applicable CMC related sections of regulatory submissions
• Write, review, and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
• Work collaboratively within multi-disciplinary team
• Participate in project management activities including creating and meeting objectives for timelines, budgets, and project goals
• Assist in stability data management and stability program (internal and external)
• Follow all applicable company SOPs, work instructions, and guidelines
• Performs other assigned tasks as required

Key Skills:

• Significant attention to detail is required as this position will author/review documents and reports that support regulatory submissions
• Extensive expertise in MS Word, Excel, and Power Point to produce high quality documents
• Project and meeting management skills
• Ability to identify technical problems and suggest resolution of the issues
• Excellent organizational, interpersonal, and decision-making skills, as well as verbal and written communication skills
• Comfortable in a fast-paced environment and able to navigate changing priorities