Associate Director, Mrna Process Development
Associate Director, mRNA Process Development ReciBioPharm is seeking a talented individual with a strong background in mRNA drug substance process development to lead our RNA Process Development team at the Watertown, MA facility. This position will play a critical role in successfully developing scalable manufacturing processes for xRNA (mRNA, self-amplifying RNA, and circular RNA) drug substances with the desired quality to facilitate client's clinical development. The successful candidate will also play a critical role in developing RecBioPharm's new xRNA platform supporting the FDA's mission of creating the next generation of fully integrated and continuous mRNA manufacturing processes.
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-amplifying 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 for 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 and 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-amplifying RNA, and circular RNA) drug substance process development.
Deep understanding of 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.
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