Process Development Scientist/Engineer
Moderna Therapeutics is the first biopharmaceutical company dedicated to the discovery and development of a new class of drugs, NativeTM proteins therapeutics. Leveraging the natural way in which proteins are made by humans, our proprietary modified messenger RNA (mRNA) enables the patient’s protein translation machinery to synthesize therapeutics. This approach envisions dosing a patient with stable, modified RNA that encodes a therapeutic protein of interest, that upon translation in a cell type, results in therapeutic treatment with high efficacy, low immunogenicity, and more biologically relevant dosing. The technology alleviates the need for laborious and expensive in vitro tissue culture or protein manufacture and purification. Our manufacturing process is cell-free. The technology is therefore a quantum advance in the field of drug development with great promise for novel ways of treating disease with direct application in the worldwide market of therapeutic biologics, which includes peptides, proteins, and antibodies. We are looking for smart, committed individuals who are looking to change the world by bringing new drugs to patients.
Job Description: This Process Development Scientist/Engineer will be part of Moderna’s dynamic and integrated product development team. As part of the PD group, the candidate will be responsible for driving the development of a robust mRNA drug substance manufacturing process focusing on platform-based improvements to facilitate and streamline the production of high purity mRNA for pre-clinical supply as well as for cGMP manufacture at an external CMO.
Ph. D/MS in biochemical engineering, chemical engineering, biochemistry, or molecular biology
- 0-7 years relevant industry experience for Ph.D level candidates / 7+ years relevant industry experience for MS level candidates
- Experience optimizing and characterizing in-vitro biochemical processes/enzymatic reactions
- Highly proficient in preparative chromatography and separations of biomolecules/macromolecules
- Experienced with molecular biology techniques
- Experience working with nucleic acids a plus
- Cell Culture experience is a plus
- Innovative scientist that possesses ability to think critically and solve problems
- Ability to multi-task effectively
- Must possess exceptional analytical skills
- Ability to communicate well with colleagues and collaborators at all levels.
- Ability to work well in a cross-functional team
- Perform enzymatic synthesis, purification, and characterization of chemically modified mRNAs.
- Implement novel mRNA drug substance process improvements and ensure robustness across platform.
- Support technology transfer to external CMO for cGMP manufacture and perform IND enabling-activities
- Provide technical/troubleshooting support for mRNA manufacturing team as needed
- Reduce overall cost of goods
- Communicate research development findings internally and externally as appropriate
- Meet product development goals under aggressive timelines
- The candidate should have demonstrated a successful track record delivering against challenging commitments with an evolving data set.
- The candidate should be confident, execution-focused, team-oriented and have the ability to motivate others. He/she will possess excellent leadership and interpersonal skills and will perform as an integrated member of a larger R&D team. As such, he/she should have significant interest in team-based innovation and collaboration, generate respect from and give respect to his/her peers, and cultivate a technical network to solve problems efficiently.
- The candidate should have strong analytical and communication skills.
- The candidate should have a working knowledge of cGMP and regulatory guidelines
- Industry experience in pharmaceutical product development or CMC type setting interfacing with cGMP environment is highly desirable
- He/she will have deep scientific grounding and aptitude in biochemistry, reaction, and purification fundamentals. Experience working with nucleic acids, conducting and optimizing enzymatic syntheses, downstream bioprocessing, and performing biophysical characterization is desirable.