Senior/Principal Scientist, Cellular Process Development and CMCAbout Moonlight Bio: Moonlight Bio is a Seattle-based, clinical stage biotech company pioneering the development of cutting-edge cell therapies for the treatment of cancer. Our team is comprised of highly collaborative individuals who are passionate about designing innovative technologies and candidates with the potential to transform the lives of cancer patients. Engaging across the full landscape of drug development, our research and development teams are pursuing opportunities in discovery research, component design and screening, preclinical modeling, process and analytical development, and partnerships necessary to enable and advance our core technologies.
Roles & Responsibilities:
We are seeking a highly motivated Senior Scientist/Principal Scientist of Process Development and CMC, to assist in process development and characterization efforts, ensuring continuity of critical material supply, and interactions with Technical Operations teams to support clinical logistics across our pipeline. This role requires a deep understanding of cell therapy manufacturing, alongside strong technical skills in CMC, and clinical supply chain management. The ideal candidate should have experience in scaling electroporation technologies for gene editing across multiple platforms and gene template types. This position is on-site in our Seattle office and offers the unique opportunity to contribute meaningfully to innovative therapies in the field of oncology.
Key responsibilities include:- Process Development and characterization
- Provide technical support for ongoing process development activities to optimize manufacturing and reduce COGMProvide oversight for process characterization activities at the CDMO to establish NORs and PARs for critical process parameters
- Cultivate and maintain strong relationships with CRO and CDMO partners to drive on-time execution of deliverables, drive successful knowledge and tech transfer, and ensure manufacturing readiness
- Maintain understanding of state-of-the-art technical advances and guide implementation of innovative technologies and methodologies to enhance process efficiency and scalability
- Perform wet lab experiments to develop and implement novel processesCMC/Technical operations
- Assist in management of critical material suppliers to ensure continuity of supply to support ongoing phase I clinical activities
- Help to establish relationships with new critical material suppliers and troubleshoot issues as they arise
- Support batch record technical review and partner with quality assurance for disposition of clinical lots
- Support strong alliances with Technical Operations teams internally and externally to ensure continuity of material supply, leukapheresis, and clinical manufacturing slot booking
- Develop content of relevant CMC sections to support regulatory submissions and interactions
- Collaborate closely with cross-functional teams to ensure seamless transition of processes from development to manufacturing
- Assist with tracking and trending of clinical manufacturing data
Qualifications:- · BS/MS with a minimum of 10 years, or PhD with minimum of 5 years of process development, CMC, or manufacturing industry experience
- Experience working with multiple types of electroporation devices and multiple gene delivery systems, especially systems capable of delivering large payloads.
- Strong knowledge of cell therapy process development principles, including experience with current technologies in viral vectors and gene editing as they relate to T cell process development and manufacturing
- Understanding of GMP requirements governing cell therapy products
- Strong wet lab skills
- Strong understanding of manufacturing equipment routinely used for T cell therapies
- Strong understanding of viral vector manufacturing principles and regulations
Experience supporting and executing CMC deliverables, including the transfer and management of cell therapy processes to GMP manufacturing with external CDMOsProven ability to operate within a Quality & Compliance framework, support execution and assessment of records, identify and mitigate Q&C risks, and support overall maturation of Q&C strategy
Understanding of, and ability to monitor and interpret, CMC-related regulatory guidelines to support regulatory filings and interactions, and ability to incorporate into phase-appropriate control strategies
Exceptional facilitation, organization, and communication skills
Willingness to travel occasionally to oversee manufacturing operations and interact with partners
Enthusiasm to work collaboratively in a fast-paced, small team setting, meet deadlines, and effectively manage multiple workstreams
What you should know:
The base pay range for this position at commencement of employment is expected to be between $135K-$170K per year.
The base pay offered may vary depending on a variety of individualized factors, including the relevance, and years, of the applicant's experience, job-related knowledge, skill set, certifications, qualifications, and/or professional licenses held, and market location.
Full time employees (and their eligible dependents) will be eligible for employee benefits including PTO, medical, dental, and vision plans from the first day of employment. Further, Moonlight supports its team members in pursuing certifications and training relevant to their roles.
At Moonlight Bio, we are committed to providing equal employment opportunities to all employees and applicants without regard to characteristics and statuses protected under applicable federal, state, and local laws. Applicants must be authorized to work in the United States. Moonlight Bio will not sponsor applicants for work visas.
Join us at Moonlight Bio and contribute to groundbreaking research that has the potential to create innovative and powerful new cancer therapies! With our collaborative, team-centric R&D approach, and our dedication to professional development, you'll have the opportunity to make a meaningful impact on patients' lives while advancing your career in the dynamic field of cell therapy.
