ReciBioPharm is seeking a talented individual with strong background in mRNA drug substance process development to lead our RNA Process Development team at Watertown, MA facility. This position will play a critical role in successfully developing scalable manufacturing processes for xRNA (mRNA, self-amplify RNA and circular RNA) drug substance with desired quality to facilitate client’s clinical development. The successful candidate will also play a critical role in developing RecBioPharm new xRNA platform supporting the FDA’s mission of creating next generation of fully integrated and continuous mRNA manufacturing process.
Essential Duties and Responsibilities
- Lead mRNA drug substance process development team for mRNA process development and non-GMP production
- Serve as an SME in RNA synthesis (in vitro transcription) and purification to drive development activities for various RNA modalities such as mRNA, self-amplify RNA and circular RNA
- Manage, mentor and grow junior team members
- Organize projects to meet timelines, produce deliverables, and meet defined success criteria
- Translate client-specific requests and tech transfer documents into internal summaries analyzing gaps and feasibility
- Take responsibility or the quality, reputation, communication and delivery in a cross functional team.
- Write technical documents and batch records to support Module 3 and other regulatory filings
- Continue to develop and drive scientific excellence in the area of mRNA manufacturing methodologies and technologies within the company as well as with world leading universities, scientific organizations and other institutional partners.
Qualifications
- Ph.D. with a minimum of 5+ years of experience; M.S. with a minimum of 8+ years of relevant industry experience
- Degree in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field
- Proven track record in xRNA (mRNA, self-amplify RNA and circular RNA) drug substance process development
- Deep understanding in RNA therapeutic modalities, RNA chemistry, and analytical assays is essential
- Innovative and up-to-date with evolving technology
- Exceptional leadership, prioritization and project management skills
- Ability to effectively document and communicate results
- Strong interpersonal skills with an eagerness to work with and support colleagues in a cross-functional collaborative environment
- Demonstrated ability to motivate and grow a team
- Knowledge of CMC and Quality functions and principles is an asset
- Knowledge of GMP production and scale-up is an asset